56008 Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations 

The basis of approval is discussed in the 

freedom of information summary. 

In addition, FDA is amending 

§ 558.311 to remove redundant text in 

an entry for combination use of singleingredient lasalocid and 

chlortetracycline in cattle feed which 

was published in error in the Federal 

Register of April 27, 2006 (71 FR 

24816). This correction is being made to 

improve the accuracy of the regulations. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

The agency has determined under 21 

CFR 25.33(a)(6) that this action is of a 

type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 558 

Animal drugs, Animal feeds. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

§ 558.311 [Amended] 

■ 2. In § 558.311, in paragraph (b)(8), 

after the number ‘‘15’’ add the words 

‘‘and 20’’; and in paragraph (e)(1)(xxvii) 

in the ‘‘Indications for use’’ column, 

remove ‘‘control of control of’’ and in its 

place add ‘‘control of’’. 

Dated: September 15, 2006. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 06–8261 Filed 9–25–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Parts 1300, 1309, 1310, 1314 

[Docket No. DEA–291I] 

RIN 1117–AB05 

Retail Sales of Scheduled Listed 

Chemical Products; Self-Certification 

of Regulated Sellers of Scheduled 

Listed Chemical Products 

AGENCY: Drug Enforcement 

Administration (DEA), Justice. 

ACTION: Interim final rule with request 

for comment. 

SUMMARY: In March 2006, the President 

signed the Combat Methamphetamine 

Epidemic Act of 2005, which establishes 

new requirements for retail sales of 

over-the-counter (nonprescription) 

products containing the List I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. The three 

chemicals can be used to manufacture 

methamphetamine illegally. DEA is 

promulgating this rule to incorporate 

the statutory provisions and make its 

regulations consistent with the new 

requirements. This action establishes 

daily and 30-day limits on the sales of 

scheduled listed chemical products to 

individuals and requires recordkeeping 

on most sales. 

DATES: Effective Dates: September 21, 

2006, except that §§ 1314.20, 1314.25, 

and 1314.30 (with the exception of 

§ 1314.30(a)(2)) are effective September 

30, 2006. Section 1314.30(a)(2) is 

effective November 27, 2006. 

Comment Date: Written comments 

must be postmarked on or before 

November 27, 2006. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–291I’’ on all written and 

electronic correspondence. Written 

comments being sent via regular mail 

should be sent to the Deputy 

Administrator, Drug Enforcement 

Administration, Washington, DC 20537, 

Attention: DEA Federal Register 

Representative/ODL. Written comments 

sent via express mail should be sent to 

DEA Headquarters, Attention: DEA 

Federal Register Representative/ODL, 

2401 Jefferson-Davis Highway, 

Alexandria, VA 22301. Comments may 

be directly sent to DEA electronically by 

sending an electronic message to 

dea.diversion.policy@usdoj.gov. 

Comments may also be sent 

electronically through http:// 

www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document is also available at the http:// 

www.regulations.gov Web site. DEA will 

accept attachments to electronic 

comments in Microsoft word, 

WordPerfect, Adobe PDF, or Excel file 

formats only. DEA will not accept any 

file format other than those specifically 

listed here. 

FOR FURTHER INFORMATION CONTACT: 

Mark W. Caverly, Chief, Liaison and 

Policy Section, Office of Diversion 

Control, Drug Enforcement 

Administration, Washington, DC 20537; 

telephone: (202) 307–7297. 

SUPPLEMENTARY INFORMATION: 

DEA’s Legal Authority 

DEA implements the Comprehensive 

Drug Abuse Prevention and Control Act 

of 1970, often referred to as the 

Controlled Substances Act (CSA) and 

the Controlled Substances Import and 

Export Act (21 U.S.C. 801–971), as 

amended. DEA publishes the 

implementing regulations for these 

statutes in Title 21 of the Code of 

Federal Regulations (CFR), Parts 1300 to 

1399. These regulations are designed to 

ensure that there is a sufficient supply 

of controlled substances for legitimate 

medical, scientific, research, and 

industrial purposes and to deter the 

diversion of controlled substances to 

illegal purposes. The CSA mandates that 

DEA establish a closed system of control 

for manufacturing, distributing, and 

dispensing controlled substances. Any 

person who manufactures, distributes, 

dispenses, imports, exports, or conducts 

research or chemical analysis with 

controlled substances must register with 

DEA (unless exempt) and comply with 

the applicable requirements for the 

activity. The CSA as amended also 

requires DEA to regulate the 

manufacture and distribution of 

chemicals that may be used to 

manufacture controlled substances 

illegally. Listed chemicals that are 

classified as List I chemicals are 

important to the manufacture of 

controlled substances. Those classified 

as List II chemicals may be used to 

manufacture controlled substances. 

On March 9, 2006, the President 

signed the Combat Methamphetamine 

Epidemic Act of 2005 (CMEA), which is 

Title VII of the USA PATRIOT 

Improvement and Reauthorization Act 

of 2005 (Pub. L. 109–177). DEA is 

promulgating this rule as an interim 

final rule rather than a proposed rule 

because the changes being made codify 

statutory provisions, some of which are 

already in effect. Parts of the statute are 

self-implementing; certain changes 

related to retail sales became effective 

upon signature (March 9, 2006), others 


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became effective on April 8, 2006, and 

still others will become effective 

September 30, 2006. An agency may 

find good cause to exempt a rule from 

certain provisions of the Administrative 

Procedure Act (APA) (5 U.S.C. 553), 

including notice of proposed 

rulemaking and the opportunity for 

public comment, if it is determined to 

be unnecessary, impracticable, or 

contrary to the public interest. Many of 

the requirements of the Combat 

Methamphetamine Epidemic Act of 

2005 included in this rulemaking were 

set out in such detail as to be selfimplementing. Therefore the changes in 

this rulemaking provide conforming 

amendments to make the language of 

the regulations consistent with that of 

the law. DEA is accepting comments on 

other aspects of this rulemaking, 

particularly those not specifically 

mandated by the Combat 

Methamphetamine Epidemic Act of 

2005. 

Combat Methamphetamine Epidemic 

Act of 2005 

The Combat Methamphetamine 

Epidemic Act of 2005 (CMEA) amends 

the CSA to change the regulations for 

selling nonprescription products that 

contain ephedrine, pseudoephedrine, 

and phenylpropanolamine, their salts, 

optical isomers, and salts of optical 

isomers. CMEA creates a new category 

of products called ‘‘scheduled listed 

chemical products.’’ Ephedrine, 

pseudoephedrine, and 

phenylpropanolamine are List I 

chemicals because they are used in, and 

important to, the illegal manufacture of 

methamphetamine. Products containing 

these List I chemicals also have 

legitimate medical uses. Ephedrine is 

used in some products for treating 

asthma. Pseudoephedrine, a 

decongestant, is a common ingredient in 

cold and allergy medications. In 

November 2000, the Food and Drug 

Administration (FDA) issued a public 

health advisory concerning 

phenylpropanolamine and requested 

that all drug companies discontinue 

marketing products containing 

phenylpropanolamine due to risk of 

hemorrhagic stroke. In response, many 

companies voluntarily reformulated 

their products to exclude 

phenylpropanolamine. Subsequently, 

on December 22, 2005, FDA published 

a Notice of Proposed Rulemaking (70 FR 

75988) proposing to categorize all overthe-counter nasal decongestants and 

weight control drug products containing 

phenylpropanolamine preparations as 

Category II, nonmonograph, i.e., not 

generally recognized as being safe for 

human consumption. Most products 

containing phenylpropanolamine 

intended for humans have been 

withdrawn from the market, but 

phenylpropanolamine is still sold by 

prescription for veterinary uses. 

Under previous CSA amendments 

(the Comprehensive Methamphetamine 

Control Act of 1996 (MCA) and the 

Methamphetamine Anti-Proliferation 

Act of 2000 (MAPA)), Congress limited 

the quantity of products containing 

ephedrine, pseudoephedrine, and 

phenylpropanolamine that could be 

sold as nonprescription drugs at retail 

(which were, along with certain liquid 

products, defined as ‘‘ordinary over-thecounter pseudoephedrine or 

phenylpropanolamine products’’) 

without recordkeeping, but generally 

exempted products sold in blister packs 

sold by ‘‘retail distributors’’. The MCA 

established thresholds for these drug 

products, including a threshold of 24 

grams of combination ephedrine 

products; single-entity ephedrine 

products had been regulated by the 

Domestic Chemical Diversion Control 

Act of 1993 (Pub. L. 103–200). MAPA 

reduced existing thresholds for 

pseudoephedrine and 

phenylpropanolamine to 9 grams per 

transaction, with each package 

containing not more than 3 grams of 

pseudoephedrine base or 

phenylpropanolamine base, but retained 

the so-called ‘‘blister pack’’ exemption. 

Because most retail outlets did not want 

to create and maintain records of sales 

or register as a retail distributor, the 

threshold for recordkeeping functioned 

for practical purposes similarly to a 

sales limit. Much of the product was 

also sold in blister packs. 

Congress determined that the existing 

limits were not sufficient to prevent 

people from buying these products and 

using them to illegally manufacture 

methamphetamine. In the Combat 

Methamphetamine Epidemic Act of 

2005, Congress adopted provisions that 

do the following: 

• Limit the quantity of each of the 

chemicals that may be sold to an 

individual in a day to 3.6 grams of the 

chemical, without regard to the number 

of transactions. 

• For nonliquids, limit packaging to 

blister packs containing no more than 2 

dosage units per blister. Where blister 

packs are not technically feasible, the 

product must be packaged in unit dose 

packets or pouches. 

• Require regulated sellers to place 

the products behind the counter or in 

locked cabinets. 

• Require regulated sellers to check 

the identity of purchasers and maintain 

a log of each sale that includes the 

purchaser’s name and address, signature 

of the purchaser, product sold, quantity 

sold, date, and time. 

• Require regulated sellers to 

maintain the logbook for at least two 

years. 

• Require regulated sellers to train 

employees in the requirements of the 

law and certify to DEA that the training 

has occurred. 

• For mobile retail vendors and mail 

order sales, require sellers to limit sales 

to an individual in a 30-day period to 

7.5 grams. 

• For individuals, limit purchases in 

a 30-day period to 9 grams, of which not 

more than 7.5 grams may be imported 

by means of a common or contract 

carrier or the U.S. Postal Service. 

The numbers of dosage units and 

milliliters (mL) that may be purchased 

under the sales limits are shown in 

Table 1 below. As noted previously, the 

FDA issued a voluntary recall on 

phenylpropanolamine products as being 

unsafe for humans so no 

phenylpropanolamine over-the-counter 

(OTC) product should be available for 

human consumption. Veterinary use is 

by prescription only. 

TABLE 1.—NUMBER OF TABLETS/MILLILITERS THAT EQUAL RETAIL TRANSACTION LIMITS (AS BASE) FOR SCHEDULED

LISTED CHEMICAL PRODUCTS

Scheduled listed chemical product 

Transaction limits 

3.6 gm 7.5 gm 9.0 gm 

Tablets 

Ephedrine: 

25 mg Ephedrine HCl ................................................................................................................................... 175 366 439 

25 mg Ephedrine Sulfate .............................................................................................................................. 186 389 466 

Pseudoephedrine (as HCl): 


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TABLE 1.—NUMBER OF TABLETS/MILLILITERS THAT EQUAL RETAIL TRANSACTION LIMITS (AS BASE) FOR SCHEDULED

LISTED CHEMICAL PRODUCTS—Continued 

Scheduled listed chemical product 

Transaction limits 

3.6 gm 7.5 gm 9.0 gm 

30 mg Pseudoephedrine HCl ....................................................................................................................... 146 305 366 

60 mg Pseudoephedrine HCl ....................................................................................................................... 73 152 183 

120 mg Pseudoephedrine HCl ..................................................................................................................... 36 76 91 

Pseudoephedrine (as Sulfate): 

30 mg Pseudoephedrine Sulfate .................................................................................................................. 155 324 389 

60 mg Pseudoephedrine Sulfate .................................................................................................................. 77 162 194 

120 mg Pseudoephedrine Sulfate ................................................................................................................ 38 81 97 

240 mg Pseudoephedrine Sulfate ................................................................................................................ 19 40 48 

Number of mL 

Ephedrine: 

6.25 mg/5 ml Ephedrine HCl ........................................................................................................................ 3,515 7,323 8,788 

Pseudoephedrine (as HCl): 

15 mg/1.6 mL Pseudoephedrine HCl ........................................................................................................... 468 976 1,171 

7.5 mg/5 mL Pseudoephedrine HCl ............................................................................................................. 2,929 6,103 7,323 

15 mg/5 mL Pseudoephedrine HCl .............................................................................................................. 1,464 3,051 3,661 

15 mg/2.5 mL Pseudoephedrine HCl ........................................................................................................... 732 1,525 1,830 

30 mg/5 mL Pseudoephedrine HCl .............................................................................................................. 732 1,525 1,830 

30 mg/2.5 mL Pseudoephedrine HCl ........................................................................................................... 366 762 915 

60 mg/5 mL Pseudoephedrine HCl .............................................................................................................. 366 762 915 

Provisions of CMEA 

Overview. Before CMEA, requirements 

for sales of products containing 

ephedrine, pseudoephedrine, and 

phenylpropanolamine, which were then 

called regulated drug products or drug 

products regulated pursuant to 21 CFR 

1300.02(b)(28)(i)(D), distinguished 

between in-person sales to a purchaser 

(retail distribution) and mail order sales, 

which covered any sale where the 

product is shipped using the Postal 

Service or any common or private 

carrier. Mail order sellers had to file 

monthly reports with DEA if they sold 

a purchaser drug products containing 

more than a threshold quantity (9 grams 

for pseudoephedrine and 

phenylpropanolamine (maximum per 

package of 3 grams), 24 grams for 

ephedrine combination products), 

regardless of how the products were 

packaged. Retailers conducting face-toface transactions had to maintain 

records for sales above the same 

thresholds except that, as noted above, 

sales of products in blister packs 

generally were not covered. The status 

of such sales was discussed in detail in 

an interpretive rule (69 FR 2862, 

January 14, 2004; corrected at 69 FR 

3198, January 22, 2004). Either type of 

seller had to register with DEA if they 

sold the products to individuals in 

amounts above the threshold quantity. 

Only two persons are registered as retail 

distributors. 

The CMEA provisions on retail sales 

create differing requirements for the 

various types of retail sales. As 

discussed further below, Table 2 

summarizes the applicability of the 

CMEA provisions as well as existing 

DEA provisions to the different types of 

sellers. 

TABLE 2.—SUMMARY OF REQUIREMENTS BY TYPE OF SELLER

Regulated sellers 

(store) 

Mobile retail 

vendors Mail order sellers 

Daily sales limit ..................................................................................................... 3.6 gm/chemical .... 3.6 gm/chemical .... 3.6 gm/chemical. 

30-day sales limit .................................................................................................. ............................... 7.5 gm ................... 7.5 gm. 

Blister packs ......................................................................................................... Yes ........................ Yes ........................ Yes. 

Storage ................................................................................................................. Behind the counter 

Locked cabinet.

Locked cabinet ...... NA. 

Logbook ................................................................................................................ Yes ........................ Yes ........................ NA. 

Customer ID .......................................................................................................... Examine photo ID Examine photo ID Verify ID. 

Train employees ................................................................................................... Yes ........................ Yes ........................ NA. 

Self-Certify ............................................................................................................ Yes ........................ Yes ........................ NA. 

Notice of misrepresentation .................................................................................. Yes ........................ Yes ........................ NA. 

Monthly reports ..................................................................................................... No .......................... No .......................... Yes. 

Theft and loss reports ........................................................................................... Yes ........................ Yes ........................ Yes. 

CMEA defines nonprescription drug 

products containing ephedrine, 

pseudoephedrine, or 

phenylpropanolamine as ‘‘scheduled 

listed chemical products.’’ Direct, inperson sales to a customer, whether at 

a permanent store or movable site (e.g., 

kiosk, flea market), are subject to new 

requirements for training of employees 

who take part in the sale of scheduled 

listed chemical products and 

certification to DEA that the employees 

have been trained. These sellers, called 

‘‘regulated sellers’’ in CMEA, must also 

check photo identifications of 

purchasers and maintain specific 

records of each sale of scheduled listed 

chemical products. Under CMEA, the 


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only sales exempt from recordkeeping 

are sales of single packages of 

pseudoephedrine where the package 

contains not more than 60 milligrams. 

DEA will issue future guidance to 

further clarify remaining questions 

about how regulated entities may meet 

this regulation’s training requirements. 

The recordkeeping and reporting 

requirements for mail order sales 

basically remain the same as under the 

previous regulations, except that a 

waiver in the prior law that covered non 

face-to-face distributions by retail 

distributors has been eliminated for 

scheduled listed chemical products. As 

a result, retail stores that deliver these 

products to customers by mail or 

delivery services will need to comply 

with the provisions for mail order sales 

reporting for these transactions. Mail 

order sellers must file monthly reports 

with DEA. CMEA adds the requirement 

that these sellers verify the purchaser’s 

identity prior to shipping. 

As noted above, CMEA changes the 

limits on retail sales. Daily sales are 

now limited to a maximum of 3.6 grams 

of each chemical in scheduled listed 

chemical products. Mobile retail 

vendors and mail order vendors must 

also limit sales to an individual 

purchaser to 7.5 grams of each chemical 

in scheduled listed chemical products 

in any 30-day period. CMEA limits 

purchases by an individual purchaser to 

9 grams of each chemical in scheduled 

listed chemical products in any 30-day 

period, not more than 7.5 grams of 

which may be imported by means of a 

private or commercial carrier or the U.S. 

Postal Service. Any imports of 

scheduled listed chemical products 

subject to the 7.5 gram purchase limit 

under CMEA must also otherwise 

comply with all other applicable 

Federal and State laws regarding their 

importation, including the Federal, 

Food, Drug, and Cosmetic Act. This 

provision is not included in this rule, 

but will be addressed in other 

rulemakings DEA is promulgating to 

implement the various provisions of the 

Combat Methamphetamine Epidemic 

Act of 2005. Finally, CMEA exempts all 

retail sellers and mail order distributors 

selling the products at retail from 

registration. The following sections 

discuss each of the statutory provisions 

in more detail. 

Definitions. CMEA revises the 

definition of ‘‘regulated transaction,’’

adds several new definitions, and 

removes the definition of ‘‘ordinary 

over-the-counter pseudoephedrine or 

phenylpropanolamine product.’’ CMEA 

adds a definition of ‘‘scheduled listed 

chemical product,’’ which means any 

nonprescription product that contains 

ephedrine, pseudoephedrine, or 

phenylpropanolamine and is marketed 

lawfully under the Federal Food, Drug, 

and Cosmetic Act. References to 

ephedrine, pseudoephedrine, or 

phenylpropanolamine include their 

salts, optical isomers, and salts of 

optical isomers. CMEA exempts 

scheduled listed chemical products sold 

at retail by a regulated seller or by 

persons that sell the product for 

personal use and ship the product by 

mail or private or common carriers (mail 

order sellers) from the definition of 

regulated transaction. It also removes 

other references to the sale of these 

chemicals in drug products from the 

definition of regulated transactions. 

DEA notes that further clarification 

regarding regulated transactions will be 

addressed in a separate rulemaking. 

These changes remove retail sellers and 

mail order sellers from the registration 

system; in practice, retail and mail order 

sellers have not registered because they 

limited sales to below threshold 

quantities and to products sold in blister 

packs. At present, only two persons are 

registered as retail distributors. 

CMEA adds definitions of ‘‘regulated 

seller,’’ to mean a retail distributor 

(including a pharmacy and mobile retail 

vendors), and ‘‘at retail,’’ to mean sale 

or purchase for personal use. It also 

revises the definition of ‘‘retail 

distributor’’ to remove the sentence 

referring to below threshold quantities. 

This change subjects all sales, except for 

sales of single packages containing not 

more than 60 milligrams of 

pseudoephedrine, to recordkeeping 

requirements. 

Sales limits. Effective April 8, 2006, 

CMEA limits sales to an individual to 

3.6 grams per day of each chemical in 

scheduled listed chemical products 

regardless of the number of purchases. 

Mobile retail vendors and mail order 

sellers may not sell an individual more 

than 7.5 grams of each chemical in 

scheduled listed chemical products in a 

30-day period. A seller who violates 

these provisions is subject to civil 

penalties and possible criminal 

penalties. 

Purchase limits. CMEA imposes a 9 

gram purchase limit in a 30-day period 

on individuals. Not more than 7.5 grams 

of the 9 grams may be imported by 

means of common/contract carrier or 

the U.S. Postal Service. Any imports of 

scheduled listed chemical products 

subject to the 7.5 gram purchase limit 

under CMEA must also otherwise 

comply with all other applicable 

Federal and State laws regarding their 

importation, including the Federal, 

Food, Drug, and Cosmetic Act. This 

provision is not included in this rule, 

but will be addressed in other 

rulemakings DEA is promulgating to 

implement the various provisions of the 

Combat Methamphetamine Epidemic 

Act of 2005. In other rulemakings based 

on new CMEA provisions, imports, 

other than this 30-day individual limit, 

are limited to DEA registrants that have 

been issued a quota to import. (These 

rulemakings will be separately 

published in the Federal Register.) A 

purchaser who violates these limits is 

subject to criminal penalties. 

Thirty-day limit. CMEA creates a 30- 

day sales limit. DEA interprets this to 

mean a rolling calendar where the sales 

limit is based on sales to the purchaser 

in the previous 30 days. DEA interprets 

the per day limit to refer to midnight to 

midnight, not a rolling 24-hour clock. 

Blister packs. Effective April 8, 2006, 

nonliquid forms of scheduled listed 

chemical products (including gel 

capsules) must be sold only in blister 

packs, with no more than two dosage 

units per blister unless blister packs are 

technically infeasible. In that case, the 

dosage units must be in unit dose 

packets or pouches. 

Product placement: Behind counter or 

locked cabinet. CMEA requires that on 

and after September 30, 2006, scheduled 

listed chemical products must be stored 

behind the counter or, if in an area 

where the public has access, in a locked 

cabinet. Although DEA is not including 

cabinet specifications in the rule, a 

locked cabinet should be substantial 

enough that it cannot be easily picked 

up and removed. In a store setting, the 

cabinet should be similar to those used 

to store items, such as cigarettes, that 

can be accessed only by sales staff. 

Logbooks. CMEA requires retail 

sellers to maintain logbooks on and after 

September 30, 2006. If a retailer 

maintains the logbook on paper, DEA is 

requiring that the logbook be bound, as 

is currently the case for records of sales 

of Schedule V controlled substances 

that are sold without a prescription. 

Bound blank logbooks and ledger books 

meeting DEA’s regulatory requirements 

are readily available on the commercial 

market. If the logbook is maintained 

electronically, the records must be 

readily retrievable by the seller and any 

DEA or other authorized law 

enforcement official. Logs must be kept 

for two years from the date the entry 

was made. The logs must include the 

information entered by the purchaser 

(name, address, signature, date, and 

time of sale) and the quantity and form 

of the product sold. 

Where the record is entered 

electronically, the computer system may 

enter the date and time automatically. 

An electronic signature system, such as 


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the ones many stores use for credit card 

purchases, may be employed to capture 

the signature for electronic logs. The 

information that the seller must enter 

may be accomplished through a pointof-sales system and bar code reader. 

DEA is aware that in some cases, such 

as pharmacy counters where the 

computer is behind the pharmacy 

counter, it may be difficult for the 

purchaser to enter the information 

electronically. DEA is seeking 

comments on whether systems currently 

used to capture signatures for credit or 

debit card purchases can be 

reprogrammed to allow customers to 

enter name and address, as well as the 

signature. DEA also recognizes that 

some purchasers will find it difficult or 

impossible to enter the information 

themselves. In these cases, the seller 

should ask for the name and address 

and enter it, rather than simply copy it 

off the photo ID. Regardless of how the 

information is entered, however, there 

must be a mechanism to allow the 

customer to sign the logbook. 

Verification of photo ID. CMEA 

requires on and after September 30, 

2006, that an individual must present an 

identification card that includes a 

photograph and is issued by a State or 

the Federal government or a document 

considered acceptable under 8 CFR 

274a.2(b)(1)(v)(A) and (B). Those 

documents currently include the 

following: 

• United States passport (unexpired 

or expired). 

• Alien Registration Receipt Card or 

Permanent Resident Card, Form I–551. 

• An unexpired foreign passport that 

contains a temporary I–551 stamp. 

• An unexpired Employment 

Authorization Document issued by the 

Immigration And Naturalization Service 

which contains a photograph, Form I–

766; Form I–688, Form I–688A, or Form 

I–688B. 

• In the case of a nonimmigrant alien 

authorized to work for a specific 

employer incident to status, an 

unexpired foreign passport with an 

Arrival-Departure Record, Form I–94, 

bearing the same name as the passport 

and containing an endorsement of the 

alien’s nonimmigrant status, so long as 

the period of endorsement has not yet 

expired and the proposed employment 

is not in conflict with any restrictions or 

limitations identified on the Form I–94. 

For individuals 16 years of age or 

older: 

• A driver’s license or identification 

card containing a photograph, issued by 

a State or an outlying possession of the 

United States. If the driver’s license or 

identification card does not contain a 

photograph, identifying information 

shall be included such as: Name, date of 

birth, sex, height, color of eyes, and 

address. 

• School identification card with a 

photograph. 

• Voter’s registration card. 

• U.S. military card or draft record. 

• Identification card issued by 

Federal, State, or local government 

agencies or entities. If the identification 

card does not contain a photograph, 

identifying information shall be 

included such as: Name, date of birth, 

sex, height, color of eyes, and address. 

• Military dependent’s identification 

card. 

• Native American tribal documents. 

• United States Coast Guard 

Merchant Mariner Card. 

• Driver’s license issued by a 

Canadian government authority. 

For individuals under age 18 who are 

unable to produce a document from the 

list above of acceptable documents for 

persons age 16 years and older: 

• School record or report card. 

• Clinic doctor or hospital record. 

• Daycare or nursery school record. 

The list of acceptable forms of 

identification, as cited in CMEA, may 

change (‘‘in effect on or after the date of 

enactment’’). DEA has no discretion to 

alter the list. 

Notice on misrepresentations. CMEA 

requires that on and after September 30, 

2006, the logbooks include a notice to 

purchasers that entering false statements 

or misrepresentations may subject the 

purchaser to criminal penalties under 

section 1001 of title 18 of the U.S. Code. 

DEA is requiring the inclusion of the 

following language in all logbooks: 

Warning: Section 1001 of Title 18, United 

States Code, states that whoever, with respect 

to the logbook, knowingly and willfully 

falsifies, conceals, or covers up by any trick, 

scheme, or device a material fact, or makes 

any materially false, fictitious, or fraudulent 

statement or representation, or makes or uses 

any false writing or document knowing the 

same to contain any materially false, 

fictitious, or fraudulent statement or entry, 

shall be fined not more than $250,000 if an 

individual or $500,000 if an organization, 

imprisoned not more than five years, or both. 

With both a bound logbook and 

electronic log, inclusion of this notice 

may present difficulties. If the purchaser 

is not able to enter the information 

electronically in a store, providing the 

notice electronically will not meet the 

requirements. If not feasible in these 

situations, one alternative is that the 

seller prominently display the notice 

where the purchaser will see it when 

entering or providing the information. 

Verification of identity for mail order 

sales. The Controlled Substances Act 

(21 U.S.C. § 830(b)(3)) requires that each 

regulated person, as defined in the Act, 

who engages in a transaction that 

involves ephedrine, pseudoephedrine, 

or phenylpropanolamine (including 

drug products containing these 

chemicals) and uses or attempts to use 

the Postal Service or any private or 

commercial carrier shall, on a monthly 

basis, submit a report of each 

transaction conducted during the 

previous month to DEA. Data contained 

in the report includes, but is not limited 

to: Name of purchaser; quantity and 

form of ephedrine, pseudoephedrine, or 

phenylpropanolamine purchased; and 

the address to which such ephedrine, 

pseudoephedrine, or 

phenylpropanolamine was sent. DEA 

has specified further information 

regarding mail order reports by 

regulation (21 CFR 1310.05). 

CMEA requires that effective April 8, 

2006, the mail order seller confirm the 

identity of the purchaser prior to 

shipping the product. CMEA requires 

DEA to establish procedures for this 

identity verification by regulation. To 

parallel the identification requirements 

for regulated sellers, and to provide 

reasonable assurance that the person 

purchasing the product is who they 

claim to be, DEA is requiring that mail 

order sellers verify the identity of the 

purchaser by obtaining a copy of an 

identification card that includes a 

photograph and is issued by a State or 

the Federal government or a document 

considered acceptable under 8 CFR 

274a.2(b)(1)(v)(A) and (B). Such a copy 

may be obtained through use of the 

Postal Service, facsimile transmission of 

a photocopy, or the scanning and 

transmission of the identification card, 

among other examples. The mail order 

seller must determine that the name and 

address on the identification card 

correspond to the name and address 

provided to the mail order seller as part 

of the sales transaction. If the 

information cannot be confirmed, the 

seller may not ship the items. 

Selling at retail. CMEA requires that 

on and after September 30, 2006, a 

regulated seller must not sell scheduled 

listed chemical products unless it has 

self-certified to DEA, through DEA’s 

Web site. The self-certification requires 

the regulated seller to confirm the 

following: 

• Its employees who will be engaged 

in the sale of scheduled listed chemical 

products have undergone training 

regarding provisions of CMEA. 

• Records of the training are 

maintained. 

• Sales to individuals do not exceed 

3.6 grams of ephedrine, 

pseudoephedrine, or 

phenylpropanolamine per day. (Mobile 


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retail vendors must also confirm that 

sales to an individual in a 30-day period 

do not exceed 7.5 grams.) 

• Nonliquid forms are packaged as 

required. 

• Scheduled listed chemical products 

are stored behind the counter or in a 

locked cabinet. 

• A written or electronic logbook 

containing the required information on 

sales of these products is properly 

maintained. 

• The logbook information will be 

disclosed only to Federal, State, or local 

law enforcement and only to ensure 

compliance with Title 21 of the United 

States Code or to facilitate a product 

recall. 

The seller must train its employees and 

self-certify before either the seller or 

individual employees may sell 

scheduled listed chemical products. The 

self-certification is subject to the 

provisions of 18 U.S.C. 1001. A 

regulated seller who knowingly or 

willfully self-certifies to facts that are 

not true is subject to fines and 

imprisonment. 

Training. DEA has developed training 

that it has made available on its Web 

site (http:// 

www.deadiversion.usdoj.gov). 

Employers must use the content of this 

training in the training of their 

employees who sell scheduled listed 

chemical products. An employer may 

include additional content to DEA’s, but 

DEA’s content must be included in the 

training. For example, a regulated seller 

may elect to incorporate DEA’s content 

into initial training for new employees. 

Training records. On and after 

September 30, 2006, each employee of 

a regulated seller who is responsible for 

delivering scheduled listed chemical 

products to purchasers or who deals 

directly with purchasers by obtaining 

payment for the scheduled listed 

chemical products must undergo 

training and must sign an 

acknowledgement of training received 

prior to selling scheduled listed 

chemical products. This record must be 

kept in the employee’s personnel file. 

Self-certification. On and after 

September 30, 2006, the regulated seller 

must self-certify to DEA as described 

above. DEA has established a Web page 

that will allow regulated sellers to 

complete the self-certification on-line 

and submit it to DEA electronically. A 

self-certification certificate will be 

generated by DEA upon receipt of the 

application. The regulated seller will 

print this self-certification certificate, or 

if the regulated seller is unable to print 

it, DEA will print and mail the 

certificate to the self-certifier. The 

regulated sellers will be classified into 

three categories: Chain stores that are 

currently controlled substance 

registrants, chain stores that are not 

registrants, and individual outlets. 

Chain stores wishing to file selfcertifications for more than 10 locations 

will have to print or copy the form 

electronically and submit the 

information to DEA by mail. DEA will 

work with these persons to facilitate this 

process. Persons interested in this selfcertification option should contact DEA 

for assistance. For current DEA 

registrants, the system will pre-populate 

the form with basic information. 

Because CMEA specifically states that 

a separate self-certification is required 

for each separate location at which 

scheduled listed chemical products are 

sold, mobile retail vendors must selfcertify for each location at which sales 

transactions occur. This selfcertification for locations is required 

even if the same person or persons sell 

at each of the different locations. 

DEA requests comments on who 

should be authorized to sign the selfcertification for the regulated seller. The 

person should be in a position to know 

that all employees who require training 

have been trained and that the retail 

outlet is complying with all other 

requirements and should be authorized 

to sign documents for the regulated 

seller. 

Time for self-certification. CMEA 

requires that regulated sellers selfcertify by September 30, 2006. Although 

CMEA appears to link self-certification 

to training of each individual who will 

deliver the products to customers, the 

high rate of employee turnover in the 

retail sector could require frequent 

submissions of self-certifications if the 

regulated seller needed to recertify each 

time a new employee is trained. DEA, 

therefore, will require regulated sellers 

to self-certify by September 30, 2006. 

When regulated sellers file the initial 

self-certification, DEA will assign them 

to groups. Each group will have an 

expiration date that will be the last day 

of a month from 12 to 23 months after 

the initial filing. After the second selfcertification, regulated sellers will be 

required to self-certify annually. It is the 

responsibility of the regulated seller to 

ensure that all employees have been 

trained prior to self-certifying each time. 

It is also the responsibility of the 

regulated seller to ensure that they selfcertify before the self-certification 

lapses. DEA requests comments on 

annual self-certifications versus 

certifications whenever new employees 

are trained or quarterly self-certification. 

Fee for self-certification. In a separate 

Notice of Proposed Rulemaking, DEA is 

proposing that regulated sellers who are 

not DEA registrants pay a fee for selfcertification. While DEA is not making 

this fee effective with this Interim Rule, 

DEA is providing background 

discussion and rationale for this 

decision here so that all persons will be 

aware of this issue. 

Section 886a of the CSA defines the 

Diversion Control Program as ‘‘the 

controlled substance and chemical 

diversion control activities of the Drug 

Enforcement Administration,’’ which 

are further defined as the ‘‘activities 

related to the registration and control of 

the manufacture, distribution and 

dispensing, importation and exportation 

of controlled substances and listed 

chemicals.’’ The CSA also states that 

reimbursements from the Diversion 

Control Fee Account ‘‘* * * shall be 

made without distinguishing between 

expenses related to controlled 

substances activities and expenses 

related to chemical activities.’’ [Pub. L. 

108–447 Consolidated Appropriations 

Act of 2005]. 

In addition, Section 111(b)(3) of the 

Departments of Commerce, Justice, and 

State, the Judiciary, and Related 

Agencies Appropriations Act of 1993 

(Pub. L. 102–395), codified at 21 U.S.C. 

886a(3), requires that ‘‘fees charged by 

the Drug Enforcement Administration 

under its diversion control program 

shall be set at a level that ensures the 

recovery of the full costs of operating 

the various aspects of that program.’’

CMEA implements new requirements 

governing the sale of scheduled listed 

chemical products, defined as 

nonprescription drug products 

containing ephedrine, pseudoephedrine, 

or phenylpropanolamine. CMEA 

requires self-certification for all 

regulated sellers of scheduled listed 

chemical products. CMEA also exempts 

retail distributors from registration 

requirements under the CSA; however, 

in practice, retail distributors have not 

previously registered with DEA because 

they limited their sales to below 

threshold quantities and to products 

sold in blister packs. 

DEA considers the self-certification 

requirements of the CMEA to fall within 

the legal definition of control as 

governed by Section 886a of the CSA 

(see above). Accordingly, these activities 

fall under the general operation of the 

Diversion Control Program and are 

subject to the requirements of the 

Appropriations Act of 1993 that 

mandates that fees charged shall be set 

at a level that ensures the recovery of 

the full costs of operating the various 

aspects of the Diversion Control 

Program. The self-certification 

requirements of CMEA fall under these 


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‘‘various aspects.’’ Therefore, in its 

Notice of Proposed Rulemaking, DEA 

will propose to charge a fee for each 

self-certification to comply with these 

statutory requirements. 

DEA is proposing, in its separate 

Notice of Proposed Rulemaking, that the 

fee for self-certification will cover all 

associated costs, including the initial 

one-time costs of setting up the selfcertification program, Web site, and 

programmatic infrastructure, as well as 

ongoing costs associated with the 

provision of self-certifications, call 

center support, maintenance of the selfcertification system, printing costs for 

certificates that regulated sellers cannot 

print, financial management, and other 

related costs. DEA must establish a 

program to train its employees to 

provide information regarding, and 

accept, self-certifications and must 

establish the infrastructure necessary for 

the program. Required systems include 

creation of history, renewal cycles, 

investigative tools, business validation 

rules, and development and 

maintenance of the self-certification 

Web site. 

In its Notice of Proposed Rulemaking, 

DEA is proposing that when regulated 

sellers submit a self-certification online 

via the DEA self-certification Web site 

that they pay a fee by credit card at the 

time of self-certification. DEA calculated 

this fee based on estimated set-up costs 

in Fiscal Year 2006 ($117,198) and 

Fiscal Year 2007 operating costs 

($1,624,443) totaling $1,741,641, as 

shown below in Table 3. The initial 

systems development and set-up costs 

will not be repeated in subsequent 

years. The operational and maintenance 

costs for Fiscal Year 2008 are estimated 

to be $1,099,782. Total annual costs 

associated with operating the selfcertification process include staff costs, 

operational and administrative costs, 

Web hosting, monitoring and 

maintenance costs (including hardware 

and software maintenance), and annual 

inflation adjustments. Therefore, DEA 

will propose in its separate Notice of 

Proposed Rulemaking, that the 89,000 

persons DEA estimates will self-certify 

with the Administration would pay a 

self-certification fee of $32 for the Fiscal 

Year 2006 through Fiscal Year 2008 

period. 

To calculate the fee, DEA divided the 

total costs for Fiscal Years 2006 through 

2008 by the anticipated population of 

affected regulated sellers of 89,000. DEA 

estimates 89,000 current retail vendors 

of scheduled listed chemical products. 

All costs are shown in the table below 

for Fiscal Years 2006 through 2008. The 

self-certification costs reflect the cost 

per each self-certification per each 

facility as required by CMEA. 

TABLE 3.—SELF-CERTIFICATION COSTS AND FEE CALCULATION

Project detail 2006 * 2007 2008 Total cost 

Planning 1 ................................................................................................................. $3,029 $36,343 $37,002 $76,373 

Design, Development, Deployment 2 ....................................................................... 43,512 703,863 71,662 819,037 

Call center, Finance, Mail room, Printing 3 .............................................................. 59,253 711,034 723,916 1,494,203 

Maintenance 4 .......................................................................................................... 11,405 173,203 176,341 360,949 

Enhancements 5 ....................................................................................................... ...................... 90,861 90,861 

Total .................................................................................................................. 117,198 1,624,443 1,099,782 2,841,423 

Population ................................................................................................................ ...................... 89,000 89,000 ......................

Cost per certification ................................................................................................ ...................... ...................... ...................... 31.92 

1Planning is the costs to the government to plan the development, design, and implementation of the self-certification online system. This item 

is the costs of three percent of the time used by five government employees to supervise and manage software development. 2 Design, development and deployment of the online self-certification system represents the cost to pay contract programmers, web designers, 

system administrators and database administrators to design, develop, and deploy the new application. These costs include testing and quality 

assurance of the new software and establishment of new security controls. The self-certification system will be designed with business validation 

rules and provide investigative tools to ensure compliance with the new legislation. 3 Call Center, finance, mail room and printing represent the following costs. 

• DEA currently operates a registration Call Center. Based on current Call Center customer service representative costs, this item includes the 

cost of the additional time required to respond to inquiries regarding the CMEA self-certification program. DEA provides call center assistance to 

approximately 400,000 persons annually. DEA estimates that CMEA will increase that population by 89,000 persons, a 23% increase. 

• DEA currently operates a registration Finance Center. Based on current Finance Center employee costs, this item includes the cost of the 

additional time required to process fees collected from CMEA self-certifications. 

• DEA currently operates a registration Mail Room. Based on current Mail Room clerical costs, this item includes cost of employee time for 

handling and mailing out of CMEA self-certification certificates if the self-certifier is unable to print the certificate. 

• DEA currently operates a Printing and Mailing Facility. Based on current Printing Costs, this item includes paper, toner, envelope, and postage costs to mail out the CMEA self-certification certificates. 4 Maintenance. This item includes all employee salaries, hardware maintenance, and software license costs associated with the daily operation 

of the self-certification system. 5Enhancements. This item is the enhancement of the system to add the ability to maintain a history of changes to records and to allow for 

yearly renewal of records. 

* 2006 is for 1 month of operations. 

To minimize administrative and 

collection burdens, it is DEA’s policy to 

round to the nearest dollar when 

calculating fees. The annual selfcertification fee will be clearly defined 

on the self-certification Web site. 

However, in setting this fee DEA notes 

that it is based on assumptions about 

the total number of regulated sellers 

who will be required to self-certify. 

Should the total number of regulated 

sellers be significantly more or less than 

89,000, DEA may adjust the selfcertification fee as appropriate through 

future rulemakings. In any case, DEA 

will not exceed its operating budget as 

authorized by Congress. 

In implementing this fee, DEA also 

notes that many of the affected regulated 

sellers are already registered with DEA 

to dispense controlled substances and 

therefore already pay a registration/ 

reregistration fee to DEA. While these 

existing registrants are required by the 

CMEA to self-certify with DEA if selling 

scheduled listed chemical products, in 

its Notice of Proposed Rulemaking, DEA 

is proposing that the self-certification 

fee be waived upon submission of an 

active DEA registration number. 

Other DEA activities associated with 

self-certification and compliance with 

CMEA include enforcement and judicial 

proceedings. CMEA gives DEA the 

authority to prohibit a regulated seller 


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from selling scheduled listed chemical 

products for certain violations of CMEA. 

If DEA issues an order to a regulated 

seller prohibiting that regulated seller 

from selling scheduled listed chemical 

products, the regulated seller is entitled 

to an administrative hearing if the seller 

files a timely request for a hearing. The 

costs of these enforcement activities and 

the subsequent proceedings must be 

supported through fees pursuant to the 

above described statutory requirements. 

DEA notes that these costs are not 

recovered in these fee calculations as 

DEA is uncertain of their utilization. 

However, once DEA is able to determine 

the frequency of use of these tools, and 

their associated costs, these costs will be 

recovered through fees associated with 

self-certification as established in future 

rulemakings. 

Relationship to State Laws 

Many States have enacted laws and/ 

or regulations that impose conditions on 

the sale of scheduled listed chemical 

products. 

• Eight states have enacted and six 

others have proposed legislation that 

makes these products Schedule V 

controlled substances. Among other 

requirements, Schedule V substances 

may be sold only by a pharmacist to 

individuals who are at least 18. A 

logbook of the sales must be maintained. 

• Sixteen states have passed laws 

limiting sales to a pharmacist or 

pharmacy technicians or requiring that 

the products be stored behind the 

counter. 

• Twenty-seven states require a photo 

ID for such purchases. 

• Twenty-six states require a signed 

logbook. 

• Twenty-seven states impose single 

transaction limits. 

• Nineteen states have monthly or 

weekly limits. 

• Twenty-seven states have 

exemptions for prescription drugs and 

various forms of over-the-counter (OTC) 

drugs (liquids, pediatric forms, etc.). 

• One state requires a prescription to 

purchase these products. 

As the list indicates, the State laws 

vary considerably. Some parts of a State 

law may be less stringent than the 

CMEA requirements; other parts may be 

more stringent. CMEA does not preempt 

those requirements under State laws/ 

regulations that are more stringent than 

the CMEA requirements. Simply put, all 

persons subject to CMEA must comply 

with the CMEA and the laws in the 

State(s) in which they sell scheduled 

listed chemical products at retail. Where 

the CMEA is less stringent than a State 

law (e.g., the State limits sales to 

licensed pharmacists or pharmacy 

technicians where CMEA does not), the 

State requirements continue to be in 

force. If there are State requirements 

that are less stringent than the CMEA 

provisions (e.g., higher daily limits, 

exemptions of some products), CMEA 

supersedes the provisions. DEA 

emphasizes that if State requirements 

for records cover the information CMEA 

mandates, the record created to meet the 

State law is sufficient to meet DEA’s 

regulation. 

Regarding quantity sold, units may be 

specified in terms of the weight of the 

product or in terms of the number of 

packages sold. Logbook systems that 

display the quantity of the product sold 

by UPC code are sufficient to meet 

DEA’s requirements. These options do 

not exclude other methods of displaying 

the quantity sold. 

DEA is accepting public comment on 

the interaction between state and federal 

logbook requirements. In addition, DEA 

is accepting public comment on the 

broader interplay and potential overlap 

between state regulations and CMEA 

requirements, and whether compliance 

with state regulations, if comparable to 

or more stringent than an associated 

CMEA requirement, should constitute 

compliance with such Federal 

requirement. 

Discussion of the Rule 

To make the rule easier to follow for 

regulated sellers and mail order/Internet 

sellers, DEA is creating a new part 1314 

that will include all requirements 

related to the sale of scheduled listed 

chemical products to end users. 

Regulations for the retail sale of these 

products that currently exist in part 

1310 will either be moved, if still 

applicable, or removed. The new 

statutory definitions of ‘‘scheduled 

listed chemical product,’’ ‘‘regulated 

seller,’’ ‘‘mobile retail vendor,’’ and ‘‘at 

retail’’ are being added to part 1300 

(Definitions). The definition of ‘‘retail 

distributor’’ is also being revised. Most 

of the new provisions in this Interim 

Final Rule are drawn from section 711 

of the USA PATRIOT Improvement and 

Reauthorization Act of 2005. 

Part 1314 is divided into four 

subparts. Subpart A contains 

requirements that apply to any retail 

sale. Subpart B applies to sales by 

regulated sellers (i.e., sales for personal 

use, both in number of sales and volume 

of sales, either directly to walk-in 

customers or in face-to-face 

transactions, by stores or mobile retail 

vendors). Subpart C applies to retail 

sales that are shipped by mail or 

common or private carriers, regardless 

of how those sales are ordered. Subpart 

D contains the procedural requirements 

for issuing and responding to an order 

to show cause why the regulated seller 

or distributor should not be prohibited 

from selling scheduled listed chemical 

products. 

Sections 1314.01 and 1314.02 simply 

state the scope and applicability of the 

part. Section 1314.03 defines ‘‘mail 

order sales’’ using the language from 

§ 1310.03(c) and further clarifies that 

mail order includes any retail sale for 

personal use where the product is 

shipped by U.S. mail or by private or 

common carriers whether the order is 

received by mail, phone, fax, the 

Internet, or any method other than a 

face-to-face transaction. 

Section 1314.05 incorporates the 

statutory requirement for blister packs 

for nonliquids unless such packaging is 

not technically feasible. 

Section 1314.10 states the regulations 

do not preempt State laws unless there 

is a positive conflict between the laws 

and the regulations such that the two 

cannot consistently stand together. This 

language is drawn from 21 U.S.C. 903. 

Section 1314.15 copies the 

requirements for reporting losses, 

including thefts, that currently exist in 

§ 1310.06. DEA emphasizes that thefts 

must be reported as well as unusual or 

excessive losses or disappearances. 

In subpart B, § 1314.20 includes the 

statutory requirements limiting sales, 

the daily limit of 3.6 grams and the 30- 

day mobile retail vendor limit of 7.5 

grams. The 30-day limit of 9 grams 

applies to purchasers who are not 

addressed by this regulation. As noted 

previously, this provision is not 

included in this rule, but will be 

addressed in other rulemakings DEA is 

promulgating to implement the various 

provisions of the Combat 

Methamphetamine Epidemic Act of 

2005. 

Section 1314.25 incorporates CMEA’s 

provisions for storing the products 

behind the counter or in a locked 

cabinet. Mobile retail vendors are 

required to store the product in a locked 

cabinet. 

Section 1314.30 covers recordkeeping 

(logbook) requirements from CMEA as 

well as requirements currently in 

§ 1310.04. In addition to CMEA’s 

requirements, DEA has copied the 

existing requirements from part 1310 

relative to where the records must be 

kept (at the place of business or at a 

central location if DEA has been 

notified). DEA is including in this 

section language stating that if a 

regulated seller is already maintaining 

records of these sales under State law, 

those records may be used to meet this 

requirement if they include the 

information specified in CMEA. 


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The part 1310 requirements 

incorporated into the amended 

regulations do not include the provision 

that a regulated seller with multiple 

locations must have a system to detect 

a person purchasing from multiple 

locations owned or operated by the 

regulated seller. CMEA in section 711(f) 

provides for a civil penalty for a person 

who sells at retail a scheduled listed 

chemical product in violation of the 

daily 3.6 gram sales limit, ‘‘knowing at 

the time of the transaction involved 

(independent of consulting the logbook 

* * *) that the transaction is a 

violation.’’ While the availability of civil 

penalties is not necessarily co-extensive 

with the chemical control requirements 

of the new law, DEA is not mandating, 

by this rule, that regulated sellers, other 

than mail order and mobile retail 

vendors, track multiple sales to 

individuals on a single day within the 

same retail outlet or across outlets of the 

same company. CMEA explicitly 

requires mail order outlets and mobile 

retail vendors to limit sales to an 

individual to 7.5 grams in a 30-day 

period; it imposes no similar 

requirement on other retail sellers to 

limit 30-day sales to individuals. The 

30-day limit of 9 grams is imposed on 

the purchaser, not the seller. 

Section 1314.35 incorporates the 

statutory requirements for training of 

sales personnel. DEA has developed 

training material, which it has made 

available on its Web site (http:// 

www.deadiversion.usdoj.gov). 

Section 1314.40 covers CMEA’s 

requirements on self-certification. As 

discussed above, DEA is setting an 

annual period for renewal of the 

certification. 

DEA has developed a web site that 

will allow many regulated sellers to 

complete and submit the selfcertification form on line and print out 

a self-certification certificate for their 

records. The information required will 

include the name and address of the 

location and a point of contact. The 

regulated sellers will be classified into 

three categories: Chain stores that are 

currently controlled substance 

registrants, chain stores that are not 

registrants, and individual outlets. 

Chain stores wishing to file selfcertifications for more than 10 locations 

will have to print or copy the form 

electronically and submit the 

information to DEA by mail. DEA will 

work with these persons to facilitate this 

process. Persons interested in this selfcertification option should contact DEA 

for assistance. For current DEA 

registrants, the system will pre-populate 

the form with basic information. 

Section 1314.45 incorporates the 

privacy protection provisions of CMEA. 

These provisions define who may access 

the sales records and the use to which 

the data may be put. They also provide 

a good faith protection to regulated 

sellers that release the data to law 

enforcement authorities. 

Section 1314.50 includes CMEA’s 

provision that states that a seller may 

take reasonable measures to guard 

against employing people who may 

present a risk of diversion. The 

measures may include asking about 

convictions of any crimes involving 

controlled substances or scheduled 

listed chemical products. 

In subpart C, § 1314.100 incorporates 

the daily and 30-day sales limits for 

mail order sales. Section 1314.105 

provides the above described 

requirements for verifying identity of 

the purchaser prior to shipment of the 

product. Section 1314.110 covers 

reports on mail order sales and is copied 

from § 1310.06. Finally, § 1314.115 

copies language from § 1310.05(f) on 

distributions not subject to reporting 

(sample packages, sales to long-term 

care facilities, prescription drugs). 

CMEA added to 21 U.S.C. 842 a 

provision that authorizes DEA to 

prohibit a regulated seller or a mail 

order seller from selling scheduled 

listed chemical products if the seller is 

found to be knowingly or recklessly in 

violation of the provisions controlling 

retail sales. To take this step, DEA must 

issue an order to show cause, as it does 

to suspend or revoke registrations. DEA 

is including in subpart D in §§ 1314.150 

and 1314.155 provisions on the process 

of issuing and responding to an order to 

show cause. These sections are taken 

from part 1309 and are the same as DEA 

uses to issue and reach a conclusion on 

orders to show cause under other DEA 

programs. If DEA issues an order to 

show cause, the regulated seller or mail 

order distributor must respond to the 

order to show cause within 30 days of 

service of the order to show cause. The 

regulated seller or mail order seller may 

request a hearing. The seller may 

continue to sell scheduled listed 

chemical products until DEA issues a 

final order. If DEA finds that a regulated 

seller or mail order distributor poses an 

imminent danger to public health or 

safety, DEA may suspend the seller’s 

right to sell scheduled listed chemical 

products pending a final decision on the 

order to show cause. 

Other Changes 

As noted above, CMEA’s new 

definitions will be added to § 1300.02. 

In addition, the definition of ‘‘regulated 

transaction’’ is revised as mandated by 

section 712 of CMEA. 

In § 1309.71, paragraph (a)(2), which 

requires certain ephedrine products to 

be stored behind the counter, is being 

removed because the new CMEA 

requirements supersede it. CMEA 

imposes the same restrictions on all 

scheduled listed chemical products 

unless they are stored in a locked 

cabinet in areas where the public has 

access. 

In § 1310.04, paragraph (f)(1)(ii) is 

revised to indicate that the thresholds 

presented in the previous paragraph and 

in paragraph (g) for ephedrine, 

pseudoephedrine, and 

phenylpropanolamine apply only to 

non-retail distribution, import, and 

export and references part 1314 for 

retail sales. The table of thresholds for 

retail distribution has been removed. 

In § 1310.05, paragraph (f)(2) is 

revised to remove retail sales of 

scheduled listed chemical products. 

Sections 1310.14 and 1310.15 are 

being removed because the CSA no 

longer treats certain ephedrine products 

differently from other scheduled listed 

chemical products. These sections are 

being replaced by new § 1310.16, which 

states that a manufacturer may apply to 

have a scheduled listed chemical 

product exempted from the 

requirements if DEA determines that the 

product cannot be used in the illicit 

manufacture of methamphetamine. DEA 

is adopting the application process that 

currently applies to ephedrine products 

that include other medically significant 

ingredients (§ 1310.14). 

Regulatory Certifications 

Administrative Procedure Act (5 U.S.C. 

553) 

The Administrative Procedure Act 

(APA) generally requires that agencies, 

prior to issuing a new rule, publish a 

Notice of Proposed Rulemaking in the 

Federal Register. The APA also 

provides, however, that agencies may be 

excepted from this requirement when 

‘‘the agency for good cause finds (and 

incorporates the finding and a brief 

statement of reasons therefore in the 

rules issued) that notice and public 

procedure thereon are impracticable, 

unnecessary, or contrary to the public 

interest.’’ 5 U.S.C. 553(b)(B). 

With publication of this interim rule, 

DEA is invoking this ‘‘good cause’’

exception to the APA’s notice 

requirement based on the combination 

of several extraordinary factors. CMEA 

requires that on and after September 30, 

2006, regulated sellers selling scheduled 

listed chemical products at retail shall 

self-certify with DEA in order to 


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continue to sell these products. CMEA 

imposes sales limits, purchase limits, 

product placement requirements, mail 

order customer identification 

requirements, and other requirements, 

some of which must be specified by 

regulation, all with an effective date of 

September 30, 2006. Based on the 

effective date of this law, it is 

impracticable for DEA to comply with 

the APA’s notice and comment 

requirements due to the limited time 

involved. Were DEA not to publish this 

Interim Rule with Request for Comment, 

regulated sellers selling scheduled listed 

chemical products at retail would not be 

able to self-certify by the date specified 

in the law. Were this not to occur, these 

regulated sellers would be forced to stop 

selling scheduled listed chemical 

products, or violate the law by doing so. 

Mail order distributors would also have 

difficulty, as DEA is required by 

regulation to establish procedures for 

these persons to identify their customers 

prior to shipping product. Without these 

regulations, mail order distributors 

would not be able to sell scheduled 

listed chemical products. Therefore, 

DEA also finds that it is contrary to the 

public interest not to issue these 

regulations as an Interim Rule, thereby 

allowing regulated sellers and mail 

order distributors to fully comply with 

the requirements of CMEA. While the 

CMEA was signed into law in March of 

2006, most of the law must be in effect 

by September 30, 2006. The broad scope 

of the new law, as well as the expedited 

effective dates, is a clear reflection of 

Congress’s concern about the nation’s 

growing methamphetamine epidemic 

and its desire to act quickly to prevent 

further illicit use of these chemicals. 

In light of these factors, DEA finds 

that ‘‘good cause’’ exists to issue this 

interim rule without engaging in 

traditional notice and comment 

rulemaking. In so doing, DEA recognizes 

that exceptions to the APA’s notice and 

comment procedures are to be 

‘‘narrowly construed and only 

reluctantly countenanced.’’ Am. Fed’n 

of Gov’t Employees v. Block, 655 F2d 

1153, 1156 (D.C.Cir. 1981) (quoting New 

Jersey Dep’t of Envtl. Prot. v. EPA, 626 

F.2d 1038, 1045 (D.C.Cir. 1980)). Based 

on the totality of the circumstances 

associated with the CMEA, however, 

DEA finds that invocation of the ‘‘good 

cause’’ exception is justified. 

As noted throughout this document, 

DEA is seeking comments on details of 

implementation, particularly related to 

self-certification, where it has 

discretion. 

Under section 553(d) of the APA, DEA 

must generally provide a 30-day delayed 

effective date for final rules. DEA may 

dispense with the 30-day delayed 

effective date requirement ‘‘for good 

cause found and published with the 

rule.’’ Since it would be unnecessary to 

provide a delayed effective date for a 

change to the law that has already taken 

effect DEA has dispensed with the 30- 

day delayed effective date requirement. 

The sales limits and blister pack 

provisions became effective on April 8, 

2006. The requirements for logbooks, 

training, and self-certification become 

effective September 30, 2006. 

Regulatory Flexibility Act 

The Deputy Administrator hereby 

certifies that this rulemaking has been 

drafted in accordance with the 

Regulatory Flexibility Act (5 U.S.C. 

605(b)). The Regulatory Flexibility Act 

(RFA) applies to rules that are subject to 

notice and comment. Because this rule 

is simply codifying statutory provisions, 

DEA has determined, as explained 

above, that public notice and comment 

are not necessary. Consequently, the 

RFA does not apply. Where DEA has 

discretion in the way in which 

provisions of CMEA are implemented, 

however, DEA is seeking public 

comment and has sought, through the 

development of training materials and 

Web sites for self-certification, to reduce 

the cost to small entities. 

Although the RFA does not apply to 

this final rule, DEA has reviewed the 

potential impacts. The rule will affect a 

substantial number of small entities, but 

DEA does not believe that it will have 

a significant economic impact on small 

entities. As shown in the next section, 

OTC medications as a whole represent 

less than two percent of sales except for 

drug stores and mail order houses. Even 

the highest estimate of the value of 

scheduled listed chemical products 

represents less than 10 percent of the 

OTC market. Consequently, the loss of 

sales, if that occurs, will reduce sales at 

most by a fraction of one percent, not a 

significant economic impact. DEA 

expects that regulated sellers will 

decide whether their sale of the 

products is great enough to justify the 

cost of compliance or whether they can 

retain sufficient sales revenues by 

shifting to non-regulated substitutes. 

The smallest stores, which DEA expects 

to be convenience stores, may limit their 

sales of the products to individual 

transactions involving packages 

containing not more than 60 milligrams 

of pseudoephedrine, which would allow 

them to avoid the recordkeeping 

requirements. In this case, their total 

cost of compliance could be about $50 

for training and self-certification. DEA is 

specifically seeking public comments 

regarding the cost of this regulation to 

small entities, using a pre-statutory 

baseline of comparison (i.e., the state of 

the market prior to the Combat 

Methamphetamine Epidemic Act of 

2005). 

Although not directly the subject of 

this rule, manufacturers and distributors 

will be affected by a reduction in sales 

of these products. The manufacturers of 

scheduled listed chemical products are 

also the manufacturers of the substitutes 

being marketed and the distributors 

handle both product lines; DEA has not 

been able to identify any manufacturer 

of these products that does not also 

market substitute products. DEA expects 

that the primary impact will be limited 

to reduction in sales that occurs because 

diversion is curbed. If the sales 

restrictions and quotas reduce the 

United States’ demand for these 

chemical products, the world 

production of the chemicals is likely to 

drop, which will make less available to 

be diverted to superlabs operated by 

drug cartels. DEA seeks comments on 

impacts on manufacturers and 

distributors. 

Executive Order 12866 

The Deputy Administrator further 

certifies that this rulemaking has been 

drafted in accordance with the 

principles in Executive Order 12866 

§ 1(b). It has been determined that this 

is ‘‘a significant regulatory action.’’

Therefore, this action has been reviewed 

by the Office of Management and 

Budget. As discussed above, this action 

is codifying statutory provisions and 

involves no agency discretion. However, 

DEA has reviewed the potential benefits 

and costs following OMB Circular A–4. 

The CMEA requirements impose the 

following costs on regulated sellers: 

• Training of employees who sell 

scheduled listed chemical product sales 

(0.5 hours). 

• Time to file the self-certification 

(0.5 hours). 

• Costs for logbooks ($47.55) or 

creating an electronic record system. 

• Additional time per sale to verify 

purchaser IDs and enter information 

into the logbook (1 to 2 minutes). 

• Storage space behind the counter or 

in locked cabinets ($200-$600). 

DEA is seeking comments regarding 

all of the above assumptions and 

estimates. 

The requirements may also affect the 

sales at regulated sellers. If a seller 

decides to avoid the requirements by 

eliminating the product line or selling 

only the available substitutes, some 

customers may seek the products from 

sellers that continue to carry them. 

Regulated sellers, manufacturers, and 

distributors will also see some reduction 


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1The 27 percent is a conservation estimate; the 

16 states represents 28 percent of the convenience 

stores in the country and 35 percent of the gas 

stations with convenience stores. 

in sales as a result of diversion from 

regulated sellers becoming more 

difficult. 

Although DEA has estimated the unit 

cost of training, certification, logbooks, 

logbook entries, and storage space, DEA 

cannot estimate the total cost of the rule 

because the following critical items are 

unknown: 

• The value of the existing market in 

these products and the number of 

transactions that this market represents. 

• The number of stores that currently 

sell these products. 

• The number and type of stores that 

will continue to sell the products, the 

number that will elect to sell only the 

substitutes, and the number that will 

limit sales of the products to individual 

transactions involving not more than 

one 60-milligram or two 30-milligram 

pseudoephedrine dosage units, which 

would not require recordkeeping, the 

most expensive part of compliance. 

• The number of customers who will 

seek out these products rather than 

purchase substitutes available on open 

shelves. 

• The number of stores that will elect 

to use bound logbooks versus using 

electronic systems. 

• The number of existing electronic 

signature capture systems that are 

capable of accepting or linking to name 

and address records. 

• The percentage of existing sales 

(and theft of the product) that is being 

diverted to illicit use. 

DEA is seeking comments and data from 

the industry that would help address 

these items and provide an estimate of 

the impact. DEA recognizes that the 

answers to some of these issues will 

evolve over time as regulated sellers and 

manufacturers adjust to consumer 

choices. For example, regulated sellers 

may see little impact beyond the initial 

costs of training and self-certification if 

most consumers elect to purchase the 

substitute products that are already 

available under the same brand names 

as scheduled listed chemical products, 

either because the consumers are 

unaware of the product change, because 

the substitutes meet the consumers’

needs, or because they are unwilling to 

spend extra time to buy scheduled listed 

chemical products. 

Regulated Sellers. The 2002 Economic 

Census data on product line sales 

indicate that about 92,000 retailers sell 

OTC medications. These include 

pharmacies, grocery stores, discount 

stores, warehouse clubs and superstores, 

convenience stores, variety stores, and 

mail order stores. In addition, up to 

40,000 gas stations with convenience 

stores may sell OTC drug products. The 

number of retailers in each sector, the 

number with pharmacies, the number 

that sell nonprescription OTC drugs, 

and the percentage of their sales 

represented by OTC drugs are shown in 

Table 4 below. DEA solicits comments 

on the number of these entities that sell 

these products. 

TABLE 4.—SECTORS SELLING SCHEDULED LISTED CHEMICAL PRODUCTS

NAICS Total 

number 

Number w 

pharmacy Number w OTC 

Percent 

without 

pharmacy 

OTC as 

percent of 

total sales * 

44511 Grocery stores ...................................................................... 66,150 19,721 26,029 70.2 1.30 

44611 Pharmacy and drug stores ................................................... 40,234 39,121 36,493 2.8 5.70 

452112 Discount department stores ................................................ 5,650 4,887 2,079 13.5 1.80 

45291 Warehouse clubs and superstores ....................................... 2,912 2,553 2,758 12.3 1.20 

Subtotal ..................................................................................... 114,946 66,282 67,359 

44512 Convenience stores .............................................................. 29,212 370 12,399 98.7 1.60 

44711 Gas stations with convenience stores .................................. 93,691 0 ** 40,068 100 ** 1.10 

45299 All other general merchandise stores *** .............................. 28,456 577 11,840 98 1.20 

4541 Electronic shopping and mail order houses ........................... 15,910 453 250 97.2 13 

Total .......................................................................................... 167,269 1,400 24,489–64,557 

*For those firms that handle the product line. 

** Drugs, health aids, beauty aids including cosmetics. *** Includes variety stores. 

Even if all gas stations with 

convenience stores sold OTC drugs, 

there would be fewer of these 

establishments than exist in the main 

sectors selling OTC drugs. Most gas 

stations and convenience stores do not 

have pharmacies; OTC products 

represent a very small percentage of 

sales for them. 

DEA cannot determine what 

percentage of those selling OTC drugs 

sell scheduled listed chemical products, 

although it is likely that outlets that 

have pharmacies sell these products. 

Because 16 States representing 27 

percent of the U.S. population already 

limit sales of these products to 

pharmacies, DEA estimates that the 

number of potentially regulated entities 

is between 89,000 and 118,000.1 This 

estimate does not specifically include 

mobile retail vendors, but DEA does not 

believe that they constitute a large 

segment of retail sellers. The actual 

number could be lower; many of the 

stores, particularly convenience stores, 

do not carry a full range of OTC drug 

products, and some may not sell this 

category of drugs. DEA seeks comment 

on this issue. Conversely, large mail 

order distributors may handle large 

quantities of scheduled listed chemical 

products. DEA also seeks comment on 

the number, size, and sales of mail order 

entities. 

Substitutes. As discussed above, 

many States have imposed sales 

restrictions on scheduled listed 

chemical products prior to CMEA. In 

reaction to those restrictions and to 

concern about diversion of their 

products, manufacturers have 

reformulated many product lines to 

alternative decongestants that cannot be 

used to make methamphetamine. These 

substitutes are being sold under the 

same product names and in boxes that 

look the same as those used for 

scheduled listed chemical products. 

One major manufacturer expected to 

have converted half of its decongestant 

product line to substitutes by January 

2006. Two of the largest drug store 


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chains do not list scheduled listed 

chemical products on their online 

stores, but offer more than 60 cold 

medications containing other 

ingredients. 

At present, there is little information 

on how consumers will react to sales 

restrictions. On April 7, 2004, 

Oklahoma made pseudoephedrine 

products Schedule V controlled 

substances, but exempted gel caps and 

liquids. According to IRI InfoScan, in 

the 52 weeks after implementation, sales 

of all pseudoephedrine products fell 

16.2 percent and sales of the substitutes 

rose by 24 percent. Sales of exempted 

gel caps rose 109.3 percent and liquids 

14.5 percent, but tablets fell 35.5 

percent. Overall, sales in the cold and 

allergy group in Oklahoma fell 3.9 

percent. Illinois, which imposed less 

stringent rules, saw little change in 

purchases, according to IRI InfoScan. 

The Slone Epidemiology Center at 

Boston University took a broader look at 

drug purchases in 2004 and found that 

between 2003 and 2004, the number of 

adults reporting use of pseudoephedrine 

fell from 7 percent to 4.8 percent. This 

decline occurred prior to State 

restrictions and to the availability of 

many substitute products, but after 

limits on purchases were set by Federal 

law and by many large chain stores. 

If national patterns reflect Oklahoma’s 

experience, a 3.9 percent drop in cold/ 

allergy medicine sales would imply a 

$117,000,000 loss in sales. However, if 

they reflect national trends reported by 

the Slone Epidemiology Center, a 2.2 

percent drop in cold/allergy medicine 

sales would imply a $33,000,000 loss in 

sales. Since market effects will occur 

within the context of increased 

marketing and distribution of 

substitutes, the direct effects on 

revenues could be lower than either 

estimate. 

It is not clear how consumers and 

retailers will react to a nationwide limit 

on all scheduled listed chemical 

product sales because the availability of 

substitute products may increase. If 

consumers continue to ask for 

scheduled listed chemical products, 

retailers will incur costs to store them 

behind the counter or in locked cabinets 

and to record every transaction. The 

purchaser will take extra time and 

possibly delay other customers who 

have to wait while the transaction is 

completed. DEA notes that in stores 

with pharmacies, the recordkeeping 

requirements established by this rule 

may direct a higher proportion of 

transactions to the pharmacy versus the 

standard checkout line. DEA is seeking 

public comment on the effect of these 

recordkeeping and product placement 

requirements on pharmacy wait times 

and any staffing costs these 

requirements generate. Alternatively, if 

few consumers seek the products, many 

retailers may decide not to carry them. 

This decision would eliminate their 

costs, but could impose a cost on the 

consumer who has to go to multiple 

stores or travel greater distances to find 

the product. Regulated sellers who 

continue to sell the products will have 

to decide how to log the sales, which 

will impose costs. DEA is seeking 

comment on the cost of logging sales, 

whether this log be paper or electronic. 

Part of each seller’s calculation will be 

whether the value of the sales is 

sufficient to offset the costs. As 

discussed above, OTC medications as a 

whole represent between one and two 

percent of the sales of sellers except for 

pharmacies and mail order sellers; 

scheduled listed chemical products 

probably represent less than 10 percent 

of those sales. For many smaller stores 

a small decline in sales, if that occurs, 

may be less costly than compliance. 

DEA has estimated that small 

convenience stores sell between $20 and 

$40 a month of these products for 

legitimate purposes (69 FR 8691, 

February 25, 2004). 

Size of the market; data issues. DEA 

has been unable to determine the size of 

the market for scheduled listed 

chemical products. The Food and Drug 

Administration reported that IMS 

Health data estimated the market is 

about $500 million; FDA further 

reported that IRI estimated the market 

was $1.5 billion. The IRI Oklahoma data 

implied that pseudoephedrine 

represented about 75 percent of the cold 

medication market, but the value other 

sources provide for the cold medication 

market in 2005 is about $4 billion. 

IRI indicated that national sales for 

the category had dropped by 0.5 percent 

between May 2004 and May 2005. A 

Kline & Company study indicated that 

sales in the cold medication category 

rose 12 percent in 2005. Part of the 

problem is that different groups appear 

to define the market segment differently, 

including a different mix of products. 

DEA seeks information on the actual 

value of the market for scheduled listed 

chemical products and the number of 

transactions. Even with the total value 

of the market, DEA would need to 

understand the value of the average 

transactions. The products are available 

in a wide variety of strengths and 

number of dosage units; the sales limits 

allow purchases of multiple packages of 

most products. DEA also seeks 

comments on the effect of the 

restrictions on product prices. At 

present, the substitutes are selling for 

prices that are equivalent to those for 

scheduled listed chemical products 

(based on maximum daily dosage units). 

The additional costs of handling 

scheduled listed chemical products 

could, however, increase their prices if 

sellers pass on the costs to consumers. 

Diversion. The limits and restrictions 

that CMEA imposes are intended to 

reduce the diversion of scheduled listed 

chemical products. Manufacturers and 

regulated sellers will see some 

reduction in sales as a result of retail 

purchases for diversion declining. DEA 

has no reliable information on the 

percentage of the market in these 

products that was diverted. DEA expects 

that as it implements other CMEA 

requirements it will have a better 

understanding of the size of the 

diversion market. Nonetheless, because 

sales of these products represent less 

than one percent of most retailer’s total 

sales, the loss of sales for diversion is 

unlikely to impose a substantial cost on 

retailers selling to legitimate purchasers. 

Implementation Costs. For most 

regulated sellers that continue to carry 

scheduled listed chemical products, the 

largest cost will be the added time to 

collect and record logbook information 

regarding the purchaser at each 

transaction. DEA estimates that it will 

take one to two minutes for the seller 

and purchaser to enter into the logbook 

the information required by CMEA—

name and address of purchaser, name 

and quantity of product sold, date and 

time of transaction, and purchaser’s 

signature—and seeks comment on this 

estimate. 

Assuming market changes may reflect 

the Oklahoma experience to a degree, a 

16 percent drop in sales of regulated 

products would change the number of 

transactions that would require 

recordkeeping to 56,490,000. Assuming 

the recordkeeping requirements add 2 

minutes to each transaction, they would 

impose an annual cost between 

$73,000,000 and $80,000,000 in terms of 

time burden. These estimates assume, 

for the low end, the average hourly wage 

of retail sales clerks ($11.86 with fringe 

benefits) plus public time ($27/hour); 

for the high end, it assumes the average 

hourly wage of a pharmacy technician 

($15.26 with fringe benefits) plus public 

time ($27/hour). 

Assuming market changes reflect data 

reported by The Slone Epidemiology 

Center, a 2.2 percent drop in sales of 

regulated products would change the 

number of transactions that would 

require recordkeeping by 2,193,000. 

Using the same assumptions regarding 

increased transaction times, this would 

imply an annual cost in terms of time 


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burden between $85,000,000 and 

$93,000,000. 

Another cost will be the costs of 

recordkeeping systems. CMEA allows 

either a logbook or an electronic record. 

DEA is seeking comments on whether 

regulated sellers will be able to use 

electronic signature capture systems to 

collect names and addresses as well as 

signatures, the cost of adapting systems 

to perform this function, and likelihood 

that sellers will do this versus using a 

bound logbook. DEA is seeking 

information from regulated sellers on 

whether they plan to limit sales to 

pharmacy or special counters or 

whether they will handle sales at 

regular checkout lines. Finally, DEA is 

seeking comments on how much 

behind-the-counter space regulated 

sellers will need to devote to these 

products, the cost of doing so, and the 

extent to which costs may be passed on 

to the consumer. 

Blister Packs. For reasons of product 

safety and the previous blister-pack 

exemption, almost all scheduled listed 

chemical products are already sold in 

blister packs. DEA seeks comments on 

whether this requirement imposes a 

burden on any manufacturers. 

Benefits. Congress passed CMEA to 

make it more difficult for individuals to 

purchase scheduled listed chemical 

products and use them to make 

methamphetamine. The retail 

restrictions are part of a series of steps 

that Congress adopted to address the 

sources of methamphetamine abuse; 

other steps include import and 

production quotas and tracking of 

international transactions. 

Methamphetamine remains the 

primary drug produced in illicit 

laboratories within the United States. 

Data from the El Paso Intelligence 

Center’s (EPIC) Clandestine Laboratory 

Database indicates that more than 

17,170 methamphetamine laboratory 

incidents in calendar year 2004 and 

12,139 incidents in calendar year 2005 

(as reported to EPIC through June 29, 

2006). According to EPIC, from January 

2000 through June 2006, there were 

7,125 laboratories reportedly using 

ephedrine and 44,380 reportedly using 

pseudoephedrine as precursor material 

for methamphetamine production. 

Additionally EPIC reports the seizure of 

51 amphetamine laboratories (using 

phenylpropanolamine) during the same 

period. The vast majority of these 

laboratories used pharmaceutical 

products containing pseudoephedrine, 

ephedrine, and phenylpropanolamine as 

the source of precursor material. 

According to the Substance Abuse 

and Mental Health Services 

Administration (SAMHSA), Drug Abuse 

Warning Network (DAWN), in 2004, the 

latest year for which data are available, 

amphetamine and methamphetamine 

was mentioned in almost 103,000 

emergency department (ED) visits; 

methamphetamine accounted for 73,400 

of these visits. These numbers represent 

a rapid increase in recent years. 

SAMHSA reported that drug abuserelated ED visits involving 

amphetamine/methamphetamine rose 

from 25,200 in 1995 to 38,960 in 2002 

and 42,500 in 2003. If the cost of the 

visit is $500, which is probably low in 

many areas, the total cost would have 

been $50 million. The DAWN mortality 

data for 33 metropolitan areas in 2003, 

the most recent year available, report 

amphetamine or methamphetamine was 

involved in 524 deaths and was the only 

drug present in 93 of those deaths. A 

University of Arkansas Study on the 

economic impact of methamphetamine 

use in Benton County, Arkansas, 

estimated that the average 

methamphetamine user cost his or her 

employer $47,500 a year, with 50 

percent of cost due to increased 

absenteeism and 32 percent due to lost 

productivity. 

The surge in methamphetamine abuse 

and the manufacture of the drug in 

clandestine laboratories has caused 

serious law enforcement and 

environmental problems, particularly in 

rural communities. Rural areas are 

frequently the site of clandestine 

laboratories because the manufacturing 

process produces distinctive odors and 

can be identified if there are close 

neighbors. Besides causing crime as 

people steal ingredients to make 

methamphetamine and steal to support 

their addiction, the clandestine 

laboratories often leave serious 

pollution behind. A laboratory can 

produce 6 to 10 pounds of hazardous 

waste for every pound of 

methamphetamine produced. Table 5 

shows the hazardous waste cleanup 

costs incurred by States and DEA by 

Fiscal Year (October 1 through 

September 30) for several previous fiscal 

years. 

TABLE 5.—STATE AND FEDERAL CLANDESTINE LABORATORY CLEANUP COSTS

Fiscal year DEA cost State/local 

meth cost Total cost 

1998 ............................................................................................................................................. $4,030,000 $1,420,000 $5,450,000 

1999 ............................................................................................................................................. 3,020,000 8,420,000 11,440,000 

2000 ............................................................................................................................................. 4,120,000 11,800,000 15,920,000 

2001 ............................................................................................................................................. 2,800,000 19,240,000 22,040,000 

2002 ............................................................................................................................................. 2,190,000 21,490,000 23,680,000 

2003 ............................................................................................................................................. 1,150,000 15,040,000 16,190,000 

2004 ............................................................................................................................................. 810,000 17,680,000 18,490,000 

2005 ............................................................................................................................................. 650,000 17,020,000 17,670,000 

2006* ............................................................................................................................................ 470,000 12,180,000 12,650,000 

* Data for fiscal year 2006 is through the third quarter (June 30, 2006). 

The Federal and State cleanups are 

generally limited to removing chemicals 

that could be reused; they do not 

address water and soil pollution that 

remain. Owners of the property are 

responsible for completing the cleanup 

of contaminated water and soil, but if 

the owner cannot pay the cost, local 

governments bear the burden or the 

contamination remains. 

The effectiveness of the control of 

retail sales can be seen in the decline in 

clandestine laboratory incidents in 

States such as Oklahoma. In 2003, 

before Oklahoma implemented retail 

sales controls, there were 1,068 

clandestine laboratory incidents in the 

State. In 2005, the first full year of the 

sales controls, there were only 217 

incidents. The CMEA provisions on 

retail sales will continue the trend of 

reducing the number of clandestine 

laboratories. This trend will reduce the 

cost to State and local governments as 

well as the hazard to law enforcement 

officers and others from exposure to the 

hazardous chemicals left behind. 

Conclusion. Because of the many 

unknowns, DEA is unable to determine 

with any certainty whether the CMEA 


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requirements will impose an annual 

cost on the economy of $100 million or 

more, the standard for an economically 

significant rule under Executive Order 

12866. If the value of the existing 

market is on the low end of the range 

($500 million), the additional costs, 

including transaction costs, would be 

considerably lower than $100 million 

even if there is no reduction in sales. If 

the value of the market is $1.5 billion 

and there is no reduction in sales, the 

cost could exceed $100 million. DEA 

considers it likely that product 

switching and reduced sales will result 

in annual costs below $100 million, but 

until the statutory requirements are 

implemented and both retailers and 

consumers respond, DEA cannot 

estimate total costs with any certainty. 

Public Comment 

To assist DEA in finalizing its 

Regulatory Impact Analysis, DEA is 

seeking public comment on the 

following questions: 

• What is the size of the market for 

products regulated under this rule? 

What proportion of the cold and allergy 

product market are pseudoephedrinebased products? 

• Using a pre-CMEA baseline, will 

this regulation have any effect on the 

prices of regulated products? If so, what 

is the magnitude of the change? 

• How many retailers may choose not 

to carry the regulated products rather 

than incur the regulatory costs? What is 

their annual sales volume with regard to 

regulated products? What is the cost 

associated with that effect? 

• If stores choose not to carry the 

regulated products, what are consumers’

travel costs associated with the 

decreased quantity of stores selling the 

product? 

• Placing products behind the 

counter may increase competition for 

space behind the counter. Will it 

increase the cost of storage space behind 

the counter? What is the cost imposed 

on the consumption of other goods? 

What, if any, effect will this have on the 

prices of other goods? 

• Among stores that opt to direct 

regulated transactions to their 

pharmacies, will this additional traffic 

have an effect on pharmacy wait times? 

Will the increase in pharmacy 

transactions require additional staffing? 

• What equipment is required for 

retailers who wish to handle regulated 

sales at the regular checkout line? What 

is its cost? 

• What are wait times for regulated 

transactions when two or more 

consumers arrive to purchase regulated 

products? 

• What is the cost to manufacturers, 

given expected demand reductions for 

regulated products? 

• To what extent, and under what 

circumstances, can substitutes for the 

regulated products reduce the expected 

cost of this regulation? 

• What are the results of any recent 

studies on the effective doses of 

substitute products and their safety at 

different levels? 

• To what extent are training and 

recordkeeping costs fixed versus 

variable? 

Paperwork Reduction Act of 1995 

CMEA mandates a number of new 

information collections and 

recordkeeping requirements. Regulated 

sellers are required to train any 

employee who will be involved in 

selling scheduled listed chemical 

products and to document the training. 

Regulated sellers must also self-certify 

to DEA that all affected employees have 

been trained and that the seller is in 

compliance with all CMEA provisions. 

Finally, CMEA mandates that each sale 

at retail be documented in a written or 

electronic logbook and that the logbooks 

be retained for two years. 

The Department of Justice, Drug 

Enforcement Administration, has 

submitted the following information 

collection request to the Office of 

Management and Budget for review and 

clearance in accordance with review 

procedures of the Paperwork Reduction 

Act of 1995. The information collection 

is published to obtain comments from 

the public and affected agencies. 

All comments and suggestions, or 

questions regarding additional 

information, to include obtaining a copy 

of the information collection instrument 

with instructions, should be directed to 

Mark W. Caverly, Chief, Liaison and 

Policy Section, Office of Diversion 

Control, Drug Enforcement 

Administration, Washington, DC 20537. 

Written comments and suggestions 

from the public and affected agencies 

concerning the collection of information 

are encouraged. Your comments on the 

information collection-related aspects of 

this rule should address one or more of 

the following four points: 

(1) Evaluate whether the collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of the 

agency’s estimate of the burden of the 

collection of information, including the 

validity of the methodology and 

assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of This Information Collection 

(1) Type of Information Collection: 

New collection. 

(2) Title of the Form/Collection: Selfcertification, Training and Logbooks for 

Regulated Sellers of Scheduled Listed 

Chemical Products. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Justice sponsoring the 

collection: Form Number: DEA Form 

597, Office of Diversion Control, Drug 

Enforcement Administration, U.S. 

Department of Justice. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: 

Primary: Business or other for-profit. 

Other: None. 

Abstract: CMEA mandates that retail 

sellers of scheduled listed chemical 

products maintain a written or 

electronic logbook of sales, retain a 

record of employee training, and 

complete a self-certification form 

verifying the training and compliance 

with CMEA provisions regarding retail 

sales of scheduled listed chemical 

products. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 89,000, 25.9 hours. 

As discussed in the previous section, 

DEA estimates that the number of 

potential regulated sellers could range 

from 89,000 to 118,000. That number 

would include a substantial number of 

convenience stores, most of which may 

not find the burden of self-certification, 

storage, recordkeeping, and training 

worth the sales of items that represent 

a very small percentage of their overall 

sales. Thus, DEA expects that the 

number of regulated sellers that will 

seek to self-certify will be no higher 

than 89,000. Consequently, DEA has 

used the lower estimate for the 

information collection. The average 

annual burden hour per respondent is 

25.9 hours, most of which is the 

additional time needed to record the 

statutorily mandated information on 

each sales transaction. 

(6) An estimate of the total public 

burden (in hours) associated with the 


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56022 Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations 

collection: 4,548,500 hours. The 

estimate includes both the burden hours 

for regulated sellers and the time 

customers would take to provide 

information during the transaction. 

Regulated sellers will need to 

maintain a record of employee training, 

self-certify, and maintain a logbook of 

transactions. DEA estimates that each 

regulated seller will spend 0.5 hours 

collecting the information and 

completing the online self-certification 

form. Completing a roster of employees 

trained is estimated to take 3 minutes 

per employee, assuming that the 

recordkeeping takes one tenth of the 

time spent on training. Finally, DEA 

estimates that having the customer enter 

information and sign the log while the 

sales person checks the photo ID will 

take two minutes per transaction. DEA 

assumes recordkeeping requirements 

will not lengthen checkout lines, and 

will not influence the transaction times 

of other customers. Further, this 

estimate does not account for scenarios 

in which two or more customers arrive 

to purchase scheduled listed chemical 

products. DEA assumes that all 

pharmacists and pharmacy technicians 

will be trained (about 300,000) plus 

100,000 other sales clerks. DEA used an 

estimate of 133 million transactions to 

develop total burden hours for 

transactions, assuming that the total 

value of the market is the midpoint of 

the estimates ($1 billion) and that the 

average value of a transaction is $8. 

(Product prices range from $4 to $14 per 

package depending on the number of 

dosage units and strength.) The number 

of transactions was reduced to 67.25 

million to account for the states that 

already have requirements for logbooks; 

this rule imposes no additional burden 

for the transactions on either purchasers 

or sellers in those states. Based on 

Bureau of Census state population 

numbers for 2005, these states represent 

49 percent of the United States 

population. Table 6 presents the burden 

hour calculations. 

TABLE 6.—ESTIMATE OF TOTAL BURDEN HOURS

Activity Unit burden hour Number of 

activities 

Total burden 

hours 

Training record ............................................................. 0.05 hour (3 minutes) ................................................... 400,000 20,000 

Self-certification ............................................................ 0.5 hour (30 minutes) ................................................... 89,000 44,500 

Transaction record ........................................................ 0.033 hour (2 minutes) ................................................. 67,250,000 2,242,000 

Customer time .............................................................. 0.033 hour (2 minutes) ................................................. 67,250,000 2,242,000 

Total ....................................................................... ....................................................................................... ........................ 4,548,500 

If additional information is required 

contact: Lynn Bryant, Department 

Clearance Officer, Information 

Management and Security Staff, Justice 

Management Division, Department of 

Justice, Patrick Henry Building, Suite 

1600, 601 D Street NW., Washington, 

DC 20530. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of Executive Order 12988 Civil 

Justice Reform. 

Executive Order 13132 

This rulemaking does not impose 

enforcement responsibilities on any 

State; nor does it diminish the power of 

any State to enforce its own laws. The 

rule does preempt State laws that are 

less stringent than the statutory 

requirements. These requirements, 

however, are mandated under CMEA 

and DEA has no authority to alter them 

or change the preemption. Accordingly, 

this rulemaking does not have 

federalism implications warranting the 

application of Executive Order 13132. 

Unfunded Mandates Reform Act of 1995 

This rule will not result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $118,000,000 or more 

in any one year, and will not 

significantly or uniquely affect small 

governments. Therefore, no actions were 

deemed necessary under the provisions 

of the Unfunded Mandates Reform Act 

of 1995. 

Congressional Review Act 

This rule is a major rule as defined by 

section 804 of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Congressional Review Act). This 

rule may result in an annual effect on 

the economy of $100,000,000 or more; it 

will not cause a major increase in costs 

or prices; or significant adverse effects 

on competition, employment, 

investment, productivity, innovation, or 

on the ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. Depending heavily on 

the assumptions used, the economic 

impact of this rule could be 

substantially higher or lower than 

$100,000,000. 

CMEA requires that on and after 

September 30, 2006, regulated sellers 

selling scheduled listed chemical 

products at retail shall self-certify with 

DEA in order to continue to sell these 

products. CMEA imposes sales limits, 

purchase limits, product placement 

requirements, mail order customer 

identification requirements, and other 

requirements, some of which must be 

specified by regulation, all with an 

effective date of September 30, 2006. 

Based on the effective date of this law, 

it is impracticable for DEA to comply 

with the requirements of CRA section 

801 pertaining to delayed effective dates 

of major rules due to the limited time 

involved. Were DEA not to publish this 

Interim Rule with Request for Comment, 

regulated sellers selling scheduled listed 

chemical products at retail would not be 

able to self-certify by the date specified 

in the law. Were this not to occur, these 

regulated sellers would be forced to stop 

selling scheduled listed chemical 

products, or violate the law by doing so. 

Mail order distributors would also have 

difficulty, as DEA is required by 

regulation to establish procedures for 

these persons to identify their customers 

prior to shipping product. Without these 

regulations, mail order distributors 

would not be able to sell scheduled 

listed chemical products. Therefore, 

DEA also finds that it is contrary to the 

public interest not to issue these 

regulations as an Interim Rule, thereby 

allowing regulated sellers and mail 

order distributors to fully comply with 

the requirements of CMEA. While the 

CMEA was signed into law in March of 

2006, most of the law must be in effect 

by September 30, 2006. The broad scope 

of the new law, as well as the expedited 

effective dates, is a clear reflection of 

Congress’s concern about the nation’s 

growing methamphetamine epidemic 

and its desire to act quickly to prevent 

further illicit use of these chemicals. In 

light of these factors, DEA finds that 

‘‘good cause’’ exists to make this Interim 

Rule with Request for Comment 


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Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations 56023 

effective September 21, 2006, except 

that §§ 1314.20, 1314.25, and 1314.30 

(with the exception of § 1314.30(a)(2)) 

are effective September 30, 2006. 

Section 1314.30(a)(2) is effective 

November 27, 2006. 

List of Subjects 

21 CFR Part 1300 

Chemicals, Drug traffic control. 

21 CFR Part 1309 

Administrative practice and 

procedure, Drug traffic control, Exports, 

Imports, Security measures. 

21 CFR Part 1310 

Drug traffic control, Exports, Imports, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 1314 

Drug traffic control, Reporting and 

recordkeeping requirements. 

■ For the reasons set out above, 21 CFR 

Chapter II is amended as follows: 

PART 1300—DEFINITIONS 

■ 1. The authority citation for part 1300 

continues to read as follows: 

Authority: 21 U.S.C. 802, 871(b), 951, 

958(f). 

■ 2. Section 1300.02 is amended by 

revising paragraphs (b)(28) and (29), 

removing paragraph (b)(31), 

redesignating paragraphs (b)(32) through 

(b)(34) as (b)(31) through (b)(33), and 

adding new paragraphs (b)(34) through 

(b)(37) to read as follows: 

§ 1300.02 Definitions related to listed 

chemicals. 

* * * * * 

(b) * * * 

(28) The term regulated transaction 

means: 

(i) A distribution, receipt, sale, 

importation, or exportation of a listed 

chemical, or an international transaction 

involving shipment of a listed chemical, 

or if the Administrator establishes a 

threshold amount for a specific listed 

chemical, a threshold amount as 

determined by the Administrator, which 

includes a cumulative threshold amount 

for multiple transactions, of a listed 

chemical, except that such term does 

not include: 

(A) A domestic lawful distribution in 

the usual course of business between 

agents or employees of a single 

regulated person; in this context, agents 

or employees means individuals under 

the direct management and control of 

the regulated person; 

(B) A delivery of a listed chemical to 

or by a common or contract carrier for 

carriage in the lawful and usual course 

of the business of the common or 

contract carrier, or to or by a 

warehouseman for storage in the lawful 

and usual course of the business of the 

warehouseman, except that if the 

carriage or storage is in connection with 

the distribution, importation, or 

exportation of a listed chemical to a 

third person, this paragraph does not 

relieve a distributor, importer, or 

exporter from compliance with parts 

1309, 1310, and 1313 of this chapter; 

(C) Any category of transaction or any 

category of transaction for a specific 

listed chemical or chemicals specified 

by regulation of the Administrator as 

excluded from this definition as 

unnecessary for enforcement of the Act; 

(D) Any transaction in a listed 

chemical that is contained in a drug 

other than a scheduled listed chemical 

product that may be marketed or 

distributed lawfully in the United States 

under the Federal Food, Drug, and 

Cosmetic Act, subject to paragraph 

(b)(28)(i)(E) of this section, unless—

(1) The Administrator has determined 

pursuant to the criteria in § 1310.10 of 

this chapter that the drug or group of 

drugs is being diverted to obtain the 

listed chemical for use in the illicit 

production of a controlled substance; 

and 

(2) The quantity of the listed chemical 

contained in the drug included in the 

transaction or multiple transactions 

equals or exceeds the threshold 

established for that chemical; 

(E) Any transaction in a scheduled 

listed chemical product that is a sale at 

retail by a regulated seller or a 

distributor required to submit reports 

under § 1310.03(c) of this chapter; or 

(F) Any transaction in a chemical 

mixture designated in §§ 1310.12 and 

1310.13 of this chapter that the 

Administrator has exempted from 

regulation. 

(ii) A distribution, importation, or 

exportation of a tableting machine or 

encapsulating machine except that such 

term does not include a domestic lawful 

distribution in the usual course of 

business between agents and employees 

of a single regulated person; in this 

context, agents or employees means 

individuals under the direct 

management and control of the 

regulated person. 

(29) The term retail distributor means 

a grocery store, general merchandise 

store, drug store, or other entity or 

person whose activities as a distributor 

relating to drug products containing 

pseudoephedrine or 

phenylpropanolamine are limited 

almost exclusively to sales for personal 

use, both in number of sales and volume 

of sales, either directly to walk-in 

customers or in face-to-face transactions 

by direct sales. Also for the purposes of 

this paragraph, a grocery store is an 

entity within Standard Industrial 

Classification (SIC) code 5411, a general 

merchandise store is an entity within 

SIC codes 5300 through 5399 and 5499, 

and a drug store is an entity within SIC 

code 5912. 

* * * * * 

(34)(i) The term scheduled listed 

chemical product means a product that 

contains ephedrine, pseudoephedrine, 

or phenylpropanolamine and may be 

marketed or distributed lawfully in the 

United States under the Federal, Food, 

Drug, and Cosmetic Act as a 

nonprescription drug. Ephedrine, 

pseudoephedrine, and 

phenylpropanolamine include their 

salts, optical isomers, and salts of 

optical isomers. 

(ii) Scheduled listed chemical product 

does not include any product that is a 

controlled substance under part 1308 of 

this chapter. In the absence of such 

scheduling by the Attorney General, a 

chemical specified in paragraph 

(b)(34)(i) of this section may not be 

considered to be a controlled substance. 

(35) The term regulated seller means 

a retail distributor (including a 

pharmacy or a mobile retail vendor), 

except that the term does not include an 

employee or agent of the distributor. 

(36) The term mobile retail vendor 

means a person or entity that makes 

sales at retail from a stand that is 

intended to be temporary or is capable 

of being moved from one location to 

another, whether the stand is located 

within or on the premises of a fixed 

facility (such as a kiosk at a shopping 

center or an airport) or whether the 

stand is located on unimproved real 

estate (such as a lot or field leased for 

retail purposes). 

(37) The term at retail, with respect to 

the sale or purchase of a scheduled 

listed chemical product, means a sale or 

purchase for personal use, respectively. 

PART 1309—REGISTRATION OF 

MANUFACTURERS, DISTRIBUTORS, 

IMPORTERS, AND EXPORTERS OF 

LIST I CHEMICALS 

■ 3. The authority citation for part 1309 

continues to read as follows: 

Authority: 21 U.S.C. 802, 821, 822, 823, 

824, 830, 871(b), 875, 877, 958. 

■ 4. Section 1309.71(a) is revised to read 

as follows: 

§ 1309.71 General security requirements. 

(a) All applicants and registrants must 

provide effective controls and 


rmajette on PROD1PC67 with RULES1
56024 Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations 

procedures to guard against theft and 

diversion of List I chemicals. Chemicals 

must be stored in containers sealed in 

such a manner as to indicate any 

attempts at tampering with the 

container. Where chemicals cannot be 

stored in sealed containers, access to the 

chemicals should be controlled through 

physical means or through human or 

electronic monitoring. 

* * * * * 

PART 1310—RECORDS AND 

REPORTS OF LISTED CHEMICALS 

AND CERTAIN MACHINES 

■ 5. The authority citation for part 1310 

continues to read as follows: 

Authority: 21 U.S.C. 802, 827(h), 830, 

871(b), 890. 

■ 6. In § 1310.04, paragraph (f)(1)(ii) is 

revised to read as follows: 

§ 1310.04 Maintenance of records. 

* * * * * 

(f) * * * 

(1) * * * 

(ii) For List I chemicals that are 

scheduled listed chemical products as 

defined in § 1300.02, the thresholds 

established in paragraphs (f)(1)(i) and (g) 

of this section apply only to non-retail 

distribution, import, and export. Sales 

of these products at retail are subject to 

the requirements of part 1314 of this 

chapter. 

* * * * * 

■ 7. Section 1310.05 is amended by 

revising paragraph (f)(2) to read as 

follows: 

§ 1310.05 Reports. 

* * * * * 

(f) * * * 

(2) Distributions of drug products by 

retail distributors that may not include 

face-to-face transactions to the extent 

that such distributions are consistent 

with the activities authorized for a retail 

distributor as specified in 

§ 1300.02(b)(29) of this chapter, except 

that this paragraph does not apply to 

sales of scheduled listed chemical 

products at retail. 

* * * * * 

■ 8. Remove § 1310.14. 

■ 9. Remove § 1310.15. 

■ 10. Add § 1310.16 to read as follows: 

§ 1310.16 Exemptions for certain 

scheduled listed chemical products. 

(a) Upon the application of a 

manufacturer of a scheduled listed 

chemical product, the Administrator 

may by regulation provide that the 

product is exempt from part 1314 of this 

chapter if the Administrator determines 

that the product cannot be used in the 

illicit manufacture of a controlled 

substance. 

(b) An application for an exemption 

under this section must contain all of 

the following information: 

(1) The name and address of the 

applicant. 

(2) The exact trade name of the 

scheduled listed chemical product for 

which exemption is sought. 

(3) The complete quantitative and 

qualitative composition of the drug 

product. 

(4) A brief statement of the facts that 

the applicant believes justify the 

granting of an exemption under this 

section. 

(5) Certification by the applicant that 

the product may be lawfully marketed 

or distributed under the Federal, Food, 

Drug, and Cosmetic Act. 

(6) The identification of any 

information on the application that is 

considered by the applicant to be a trade 

secret or confidential and entitled to 

protection under U.S. laws restricting 

the public disclosure of such 

information by government employees. 

(c) The Administrator may require the 

applicant to submit additional 

documents or written statements of fact 

relevant to the application that he 

deems necessary for determining if the 

application should be granted. 

(d) Within a reasonable period of time 

after the receipt of a completed 

application for an exemption under this 

section, the Administrator shall notify 

the applicant of acceptance or nonacceptance of the application. If the 

application is not accepted, an 

explanation will be provided. The 

Administrator is not required to accept 

an application if any of the information 

required in paragraph (b) of this section 

or requested under paragraph (c) of this 

section is lacking or not readily 

understood. The applicant may, 

however, amend the application to meet 

the requirements of paragraphs (b) and 

(c) of this section. 

(e) If the application is accepted for 

filing, the Administrator shall issue and 

publish in the Federal Register an order 

on the application, which shall include 

a reference to the legal authority under 

which the order is based. This order 

shall specify the date on which it shall 

take effect. 

(f) The Administrator shall permit any 

interested person to file written 

comments on or objections to the order. 

If any comments or objections raise 

significant issues regarding any findings 

of fact or conclusions of law upon 

which the order is based, the 

Administrator shall immediately 

suspend the effectiveness of the order 

until he may reconsider the application 

in light of the comments and objections 

filed. Thereafter, the Administrator shall 

reinstate, revoke, or amend the original 

order as deemed appropriate. 

■ 11. Part 1314 is added to 21 CFR 

Chapter II to read as follows: 

PART 1314—RETAIL SALE OF 

SCHEDULED LISTED CHEMICAL 

PRODUCTS 

Subpart A—General 

1314.01 Scope. 

1314.02 Applicability. 

1314.03 Definitions. 

1314.05 Requirements regarding packaging 

of nonliquid forms. 

1314.10 Effect on state laws. 

1314.15 Loss reporting. 

Subpart B—Sales by Regulated Sellers 

1314.20 Restrictions on sales quantity. 

1314.25 Requirements for retail 

transactions. 

1314.30 Recordkeeping for retail 

transactions. 

1314.35 Training of sales personnel. 

1314.40 Self-certification. 

1314.45 Privacy protections. 

1314.50 Employment measures. 

Subpart C—Mail-Order Sales 

1314.100 Sales limits for mail-order sales. 

1314.105 Verification of identity for mailorder sales. 

1314.110 Reports for mail-order sales. 

1314.115 Distributions not subject to 

reporting requirements. 

Subpart D—Order To Show Cause 

1314.150 Order to show cause. 

1314.155 Suspension pending final order. 

Authority: 21 U.S.C. 802, 830, 842, 871(b), 

875, 877. 

Subpart A—General 

§ 1314.01 Scope. 

This part specifies the requirements 

for retail sales of scheduled listed 

chemical products to individuals for 

personal use. 

§ 1314.02 Applicability. 

(a) This part applies to the following 

regulated persons who sell scheduled 

listed chemical products for personal 

use: 

(1) Regulated sellers of scheduled 

listed chemical products sold at retail 

for personal use through face-to-face 

sales at stores or mobile retail vendors. 

(2) Regulated persons who engage in 

a transaction with a non-regulated 

person and who ship the products to the 

non-regulated person by the U.S. Postal 

Service or by private or common 

carriers. 

(b) The requirements in subpart A 

apply to all regulated persons subject to 

this part. The requirements in subpart B 

apply to regulated sellers as defined in 


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§ 1300.02 of this chapter. The 

requirements in subpart C apply to 

regulated persons who ship the 

products to the customer by the U.S. 

Postal Service or by private or common 

carriers. 

§ 1314.03 Definitions. 

As used in this part, the term ‘‘mailorder sale’’ means a retail sale of 

scheduled listed chemical products for 

personal use where a regulated person 

uses or attempts to use the U.S. Postal 

Service or any private or commercial 

carrier to deliver the product to the 

customer. Mail-order sale includes 

purchase orders submitted by phone, 

mail, fax, Internet, or any method other 

than face-to-face transaction. 

§ 1314.05 Requirements regarding 

packaging of nonliquid forms. 

A regulated seller or mail order 

distributor may not sell a scheduled 

listed chemical product in nonliquid 

form (including gel caps) unless the 

product is packaged either in blister 

packs, with each blister containing no 

more than two dosage units or, if blister 

packs are technically infeasible, in unit 

dose packets or pouches. 

§ 1314.10 Effect on State laws. 

Nothing in this part preempts State 

law on the same subject matter unless 

there is a positive conflict between this 

part and a State law so that the two 

cannot consistently stand together. 

§ 1314.15 Loss reporting. 

(a) Each regulated person must report 

to the Special Agent in Charge of the 

DEA Divisional Office for the area in 

which the regulated person making the 

report is located, any unusual or 

excessive loss or disappearance of a 

scheduled listed chemical product 

under the control of the regulated 

person. The regulated person 

responsible for reporting a loss in-transit 

is the supplier. 

(b) Each report submitted under 

paragraph (a) of this section must, 

whenever possible, be made orally to 

the DEA Divisional Office for the area in 

which the regulated person making the 

report is located at the earliest 

practicable opportunity after the 

regulated person becomes aware of the 

circumstances involved. 

(c) Written reports of losses must be 

filed within 15 days after the regulated 

person becomes aware of the 

circumstances of the event. 

(d) A report submitted under this 

section must include a description of 

the circumstances of the loss (in-transit, 

theft from premises, etc.). 

(e) A suggested format for the report 

is provided below: 

Regulated Person 

Registration number (if applicable) llll

Name llllllllllllllllll

Business address llllllllllll

City llllllllllllllllll

State llllllllllllllllll

Zip lllllllllllllllllll

Business phone lllllllllllll

Date of loss lllllllllllllll

Type of loss lllllllllllllll

Description of circumstances lllllll

Subpart B—Sales by Regulated Sellers 

§ 1314.20 Restrictions on sales quantity. 

(a) Without regard to the number of 

transactions, a regulated seller 

(including a mobile retail vendor) may 

not in a single calendar day sell any 

purchaser more than 3.6 grams of 

ephedrine base, 3.6 grams of 

pseudoephedrine base, or 3.6 grams of 

phenylpropanolamine base in 

scheduled listed chemical products. 

(b) A mobile retail vendor may not in 

any 30-day period sell an individual 

purchaser more than 7.5 grams of 

ephedrine base, 7.5 grams of 

pseudoephedrine base, or 7.5 grams of 

phenylpropanolamine base in 

scheduled listed chemical products. 

§ 1314.25 Requirements for retail 

transactions. 

(a) Each regulated seller must ensure 

that sales of a scheduled listed chemical 

product at retail are made in accordance 

with this section and § 1314.20. 

(b) The regulated seller must place the 

product so that customers do not have 

direct access to the product before the 

sale is made (in this paragraph referred 

to as ‘‘behind-the-counter’’ placement). 

For purposes of this paragraph, a 

behind-the-counter placement of a 

product includes circumstances in 

which the product is stored in a locked 

cabinet that is located in an area of the 

facility where customers do have direct 

access. Mobile retail vendors must place 

the product in a locked cabinet. 

(c) The regulated seller must deliver 

the product directly into the custody of 

the purchaser. 

§ 1314.30 Recordkeeping for retail 

transactions. 

(a)(1) Except for purchase by an 

individual of a single sales package 

containing not more than 60 milligrams 

of pseudoephedrine, the regulated seller 

must maintain, in accordance with 

criteria issued by the Administrator, a 

written or electronic list of each 

scheduled listed chemical product sale 

that identifies the products by name, the 

quantity sold, the names and addresses 

of the purchasers, and the dates and 

times of the sales (referred to as the 

‘‘logbook’’). The logbook may be 

maintained on paper or in electronic 

form. 

(2) Effective November 27, 2006, if a 

logbook is maintained on paper, it must 

be created and maintained in a bound 

record book. 

(b) The regulated seller must not sell 

a scheduled listed chemical product at 

retail unless the purchaser does the 

following: 

(1) Presents an identification card that 

provides a photograph and is issued by 

a State or the Federal Government, or a 

document that, with respect to 

identification, is considered acceptable 

for purposes of 8 CFR 274a.2(b)(1)(v)(A) 

and 274a.2(b)(1)(v)(B). 

(2) Signs the logbook and enters in the 

logbook his or her name, address, and 

the date and time of the sale. 

(c) For records created electronically, 

the regulated seller may use an 

electronic signature system to capture 

the signature and may have the 

computer automatically enter the date 

and time of the sale. The regulated seller 

may ask the purchaser for their name 

and address and enter information if it 

is not feasible for the purchaser to enter 

the information electronically. 

(d) The regulated seller must 

determine that the name entered in the 

logbook corresponds to the name 

provided on identification presented 

and that the date and time entered are 

correct. 

(e) The regulated seller must enter in 

the logbook the name of the product and 

the quantity sold. Examples of methods 

of recording the quantity sold include 

the weight of the product per package 

and number of packages of each 

chemical, the cumulative weight of the 

product for each chemical, or quantity 

of product by Universal Product Code. 

These examples do not exclude other 

methods of displaying the quantity sold. 

For electronic records, the regulated 

seller may use a point-of-sale and bar 

code reader. Such electronic records 

must be provided pursuant to paragraph 

(i) of this section in a human readable 

form such that the requirements of 

paragraph (a)(1) of this section are 

satisfied. 

(f) The regulated seller must include 

in the logbook or display by the 

logbook, the following notice: 

Warning: Section 1001 of Title 18, United 

States Code, states that whoever, with respect 

to the logbook, knowingly and willfully 

falsifies, conceals, or covers up by any trick, 

scheme, or device a material fact, or makes 

any materially false, fictitious, or fraudulent 

statement or representation, or makes or uses 

any false writing or document knowing the 

same to contain any materially false, 

fictitious, or fraudulent statement or entry, 

shall be fined not more than $250,000 if an 


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56026 Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations 

individual or $500,000 if an organization, 

imprisoned not more than five years, or both. 

(g) The regulated seller must maintain 

each entry in the logbook for not fewer 

than 2 years after the date on which the 

entry is made. 

(h) A record under this section must 

be kept at the regulated seller’s place of 

business where the transaction 

occurred, except that records may be 

kept at a single, central location of the 

regulated seller if the regulated seller 

has notified the Administration of the 

intention to do so. Written notification 

must be submitted by registered or 

certified mail, return receipt requested, 

to the Special Agent in Charge of the 

DEA Divisional Office for the area in 

which the records are required to be 

kept. 

(i) The records required to be kept 

under this section must be readily 

retrievable and available for inspection 

and copying by authorized employees of 

the Administration under the provisions 

of 21 U.S.C. 880. 

(j) A record developed and 

maintained to comply with a State law 

may be used to meet the requirements 

of this section if the record includes the 

information specified in this section. 

§ 1314.35 Training of sales personnel. 

Each regulated seller must ensure that 

its sales of a scheduled listed chemical 

product at retail are made in accordance 

with the following: 

(a) In the case of individuals who are 

responsible for delivering the products 

into the custody of purchasers or who 

deal directly with purchasers by 

obtaining payments for the products, the 

regulated seller has submitted to the 

Administration a self-certification that 

all such individuals have, in accordance 

with criteria issued by the 

Administration, undergone training 

provided by the regulated seller to 

ensure that the individuals understand 

the requirements that apply under this 

part. 

(b) The regulated seller maintains a 

copy of each self-certification and all 

records demonstrating that individuals 

referred to in paragraph (a) of this 

section have undergone the training. 

§ 1314.40 Self-certification. 

(a) A regulated seller must submit to 

the Administration the self-certification 

referred to in § 1314.35(a) in order to 

sell any scheduled listed chemical 

product. The certification is not 

effective for purposes of this section 

unless, in addition to provisions 

regarding the training of individuals 

referred to in § 1314.35(a), the 

certification includes a statement that 

the regulated seller understands each of 

the requirements that apply under this 

part and agrees to comply with the 

requirements. 

(b) When a regulated seller files the 

initial self-certification, the 

Administration will assign the regulated 

seller to one of twelve groups. The 

expiration date of the self-certification 

for all regulated sellers in any group 

will be the last day of the month 

designated for that group. In assigning a 

regulated seller to a group, the 

Administration may select a group with 

an expiration date that is not less than 

12 months or more than 23 months from 

the date of the self-certification. After 

the initial certification period, the 

regulated seller must update the selfcertifications annually. 

(c) The regulated seller must provide 

a separate certification for each place of 

business at which the regulated seller 

sells scheduled listed chemical products 

at retail. 

§ 1314.45 Privacy protections. 

To protect the privacy of individuals 

who purchase scheduled listed 

chemical products, the disclosure of 

information in logbooks under § 1314.15 

is restricted as follows: 

(a) The information shall be disclosed 

as appropriate to the Administration 

and to State and local law enforcement 

agencies. 

(b) The information in the logbooks 

shall not be accessed, used, or shared 

for any purpose other than to ensure 

compliance with this title or to facilitate 

a product recall to protect public health 

and safety. 

(c) A regulated seller who in good 

faith releases information in a logbook 

to Federal, State, or local law 

enforcement authorities is immune from 

civil liability for the release unless the 

release constitutes gross negligence or 

intentional, wanton, or willful 

misconduct. 

§ 1314.50 Employment measures. 

A regulated seller may take reasonable 

measures to guard against employing 

individuals who may present a risk with 

respect to the theft and diversion of 

scheduled listed chemical products, 

which may include, notwithstanding 

State law, asking applicants for 

employment whether they have been 

convicted of any crime involving or 

related to such products or controlled 

substances. 

Subpart C—Mail-Order Sales 

§ 1314.100 Sales limits for mail-order 

sales. 

(a) Each regulated person who makes 

a sale at retail of a scheduled listed 

chemical product and is required under 

§ 1310.03(c) of this chapter to submit a 

report of the sales transaction to the 

Administration may not in a single 

calendar day sell to any purchaser more 

than 3.6 grams of ephedrine base, 3.6 

grams of pseudoephedrine base, or 3.6 

grams of phenylpropanolamine base in 

scheduled listed chemical products. 

(b) Each regulated person who makes 

a sale at retail of a scheduled listed 

chemical product and is required under 

§ 1310.03(c) of this chapter to submit a 

report of the sales transaction to the 

Administration may not in any 30-day 

period sell to an individual purchaser 

more than 7.5 grams of ephedrine base, 

7.5 grams of pseudoephedrine base, or 

7.5 grams of phenylpropanolamine base 

in scheduled listed chemical products. 

§ 1314.105 Verification of identity for mailorder sales. 

(a) Each regulated person who makes 

a sale at retail of a scheduled listed 

chemical product and is required under 

§ 1310.03(c) of this chapter to submit a 

report of the sales transaction to the 

Administration must, prior to shipping 

the product, receive from the purchaser 

a copy of an identification card that 

provides a photograph and is issued by 

a State or the Federal Government, or a 

document that, with respect to 

identification, is considered acceptable 

for purposes of 8 CFR 274a.2(b)(1)(v)(A) 

and 274a.2(b)(1)(v)(B). Prior to shipping 

the product, the regulated person must 

determine that the name and address on 

the identification correspond to the 

name and address provided by the 

purchaser as part of the sales 

transaction. If the regulated person 

cannot verify the identities of both the 

purchaser and the recipient, the person 

may not ship the scheduled listed 

chemical product. 

(b) If the product is being shipped to 

a third party, the regulated person must 

comply with the requirements of 

paragraph (a) to verify that both the 

purchaser and the person to whom the 

product is being shipped live at the 

addresses provided. If the regulated 

person cannot verify the identities of 

both the purchaser and the recipient, 

the person may not ship the scheduled 

listed chemical product. 

§ 1314.110 Reports for mail-order sales. 

(a) Each regulated person required to 

report under § 1310.03(c) of this chapter 

must either: 

(1) Submit a written report, 

containing the information set forth in 

paragraph (b) of this section, on or 

before the 15th day of each month 

following the month in which the 

distributions took place. The report 

must be submitted under company 


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letterhead, signed by the person 

authorized to sign on behalf of the 

regulated seller, to the Drug and 

Chemical Evaluation Section, Office of 

Diversion Control, Drug Enforcement 

Administration, Washington, DC 20537; 

or 

(2) Upon request to and approval by 

the Administration, submit the report in 

electronic form, either via computer 

disk or direct electronic data 

transmission, in such form as the 

Administration shall direct. Requests to 

submit reports in electronic form should 

be submitted to the Drug and Chemical 

Evaluation Section, Office of Diversion 

Control, Drug Enforcement 

Administration, Washington, DC 20537, 

ATTN: Electronic Reporting. 

(b) Each monthly report must provide 

the following information for each 

distribution: 

(1) Supplier name and registration 

number; 

(2) Purchaser’s name and address; 

(3) Name/address shipped to (if 

different from purchaser’s name/ 

address); 

(4) Method used to verify the identity 

of the purchaser and, where applicable, 

person to whom product is shipped; 

(5) Name of the chemical contained in 

the scheduled listed chemical product 

and total quantity shipped (e.g. 

pseudoephedrine, 3 grams); 

(6) Date of shipment; 

(7) Product name; 

(8) Dosage form (e.g., tablet, liquid); 

(9) Dosage strength (e.g., 30mg, 60mg, 

per dose etc.); 

(10) Number of dosage units (e.g., 100 

doses per package); 

(11) Package type (blister pack, etc.); 

(12) Number of packages; 

(13) Lot number. 

§ 1314.115 Distributions not subject to 

reporting requirements. 

(a) The following distributions to 

nonregulated persons are not subject to 

the reporting requirements in 

§ 1314.110: 

(1) Distributions of sample packages 

when those packages contain not more 

than two solid dosage units or the 

equivalent of two dosage units in liquid 

form, not to exceed 10 milliliters of 

liquid per package, and not more than 

one package is distributed to an 

individual or residential address in any 

30-day period. 

(2) Distributions by retail distributors 

that may not include face-to-face 

transactions to the extent that such 

distributions are consistent with the 

activities authorized for a retail 

distributor as specified in 

§ 1300.02(b)(29) of this chapter, except 

that this paragraph (a)(2) does not apply 

to sales of scheduled listed chemical 

products at retail. 

(3) Distributions to a resident of a long 

term care facility or distributions to a 

long term care facility for dispensing to 

or for use by a resident of that facility. 

(4) Distributions in accordance with a 

valid prescription. 

(b) The Administrator may revoke any 

or all of the exemptions listed in 

paragraph (a) of this section for an 

individual regulated person if the 

Administrator finds that drug products 

distributed by the regulated person are 

being used in violation of the 

regulations in this chapter or the 

Controlled Substances Act. 

Subpart D—Order to Show Cause 

§ 1314.150 Order To show cause. 

(a) If, upon information gathered by 

the Administration regarding any 

regulated seller or a distributor required 

to submit reports under § 1310.03(c) of 

this chapter, the Administrator 

determines that a regulated seller or 

distributor required to submit reports 

under § 1310.03(c) of this chapter has 

sold a scheduled listed chemical 

product in violation of Section 402 of 

the Act (21 U.S.C. 842(a)(12) or (13)), 

the Administrator will serve upon the 

regulated seller or distributor an order 

to show cause why the regulated seller 

or distributor should not be prohibited 

from selling scheduled listed chemical 

products. 

(b) The order to show cause shall call 

upon the regulated seller or distributor 

to appear before the Administrator at a 

time and place stated in the order, 

which shall not be less than 30 days 

after the date of receipt of the order. The 

order to show cause shall also contain 

a statement of the legal basis for such 

hearing and for the prohibition and a 

summary of the matters of fact and law 

asserted. 

(c) Upon receipt of an order to show 

cause, the regulated seller or distributor 

must, if he desires a hearing, file a 

request for a hearing as specified in 

subpart D of part 1316 of this chapter. 

If a hearing is requested, the 

Administrator shall hold a hearing at 

the time and place stated in the order, 

as provided in part 1316 of this chapter. 

(d) When authorized by the 

Administrator, any agent of the 

Administration may serve the order to 

show cause. 

§ 1314.155 Suspension pending final 

order. 

(a) The Administrator may suspend 

the right to sell scheduled listed 

chemical products simultaneously with, 

or at any time subsequent to, the service 

upon the seller or distributor required to 

file reports under § 1310.03(c) of this 

chapter of an order to show cause why 

the regulated seller or distributor should 

not be prohibited from selling 

scheduled listed chemical products, in 

any case where he finds that there is an 

imminent danger to the public health or 

safety. If the Administrator so suspends, 

he shall serve with the order to show 

cause under § 1314.150 an order of 

immediate suspension that shall contain 

a statement of his findings regarding the 

danger to public health or safety. 

(b) Upon service of the order of 

immediate suspension, the regulated 

seller or distributor shall, as instructed 

by the Administrator: 

(1) Deliver to the nearest office of the 

Administration or to authorized agents 

of the Administration all of the 

scheduled listed chemical products in 

his or her possession; or 

(2) Place all of the scheduled listed 

chemical products under seal as 

described in Section 304 of the Act (21 

U.S.C. 824(f)). 

(c) Any suspension shall continue in 

effect until the conclusion of all 

proceedings upon the prohibition, 

including any judicial review, unless 

sooner withdrawn by the Administrator 

or dissolved by a court of competent 

jurisdiction. Any regulated seller or 

distributor whose right to sell scheduled 

listed chemical products is suspended 

under this section may request a hearing 

on the suspension at a time earlier than 

specified in the order to show cause 

under § 1314.150, which request shall 

be granted by the Administrator, who 

shall fix a date for such hearing as early 

as reasonably possible. 

Dated: September 20, 2006. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 06–8194 Filed 9–21–06; 10:25 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 593 

[Docket No. NHTSA–2006–25686] 

List of Nonconforming Vehicles 

Decided To Be Eligible for Importation 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), DOT. 

ACTION: Final rule. 

SUMMARY: This document revises the list 

of vehicles not originally manufactured 

to conform to the Federal motor vehicle 


rmajette on PROD1PC67 with RULES1